Obesity

Polycystic ovary syndrome (PCOS) is associated with an increased risk of gestational diabetes, but this risk is heightened significantly in the presence of obesity, according to new research.

In a population-based cohort study that included more than 1.2 million hospital live births, PCOS was associated with a 5% increase in risk for gestational diabetes. Almost 90% of this association was mediated by obesity.

“Women with PCOS are at higher risk, but it’s only 5% higher than the general population. However, that risk rises substantially with obesity,” senior author Maria P. Velez, MD, PhD, clinician-scientist and associate professor of obstetrics and gynecology at Queen’s University, Kingston, Ont., said in an interview. “Our study highlights the need for counseling our patients about the importance of weight optimization, ideally starting with lifestyle changes like diet and exercise.”The findings were published  in the Journal of Obstetrics and Gynaecology Canada.
 

Major mediator

The estimated prevalence of PCOS is 8%-13%, and affected patients often present with anovulation, hyperandrogenism, obesity, metabolic syndrome, and infertility. Prepregnancy insulin resistance is common among women with PCOS and may play a major part in the pathogenesis of gestational diabetes. In addition, PCOS is often accompanied by excess weight gain; about 60% of women with PCOS are overweight or obese.

Previous research has shown that PCOS is a risk factor for gestational diabetes independent of obesity, while other research has shown that obesity has an important effect on this risk.

For the current study, the researchers used causal mediation analysis to elucidate more clearly the effect of obesity on the development of gestational diabetes among patients with PCOS. No previous study has used causal mediation analysis to examine this relationship.

Using data from linked universal health databases in Ontario, the researchers analyzed data on 1,268,901 births between 2006 and 2018. Of these births, 386,748 were associated with maternal PCOS.

The rate of gestational diabetes was higher among women with PCOS (60.2 per 1000 births), compared with women without PCOS (48.6 per 1,000 births). The finding resulted in an adjusted relative risk of 1.05. Obesity mediated 89.7% of this association.

“We hope that these data will inform preconception counseling and gestational diabetes screening in pregnant women with PCOS,” said Dr. Velez. “We have the data now to counsel our patients on the importance of weight management before pregnancy. But we need more resources, such as specialized clinics, to help these patients cope with managing their weight. We can tell our patients to work on their weight management, but they need much more support from the health care system.”
 

Results ‘not surprising’

Commenting on the study, Francine Hippolyte, MD, vice chair of obstetrics and gynecology at Long Island Jewish Medical Center, Katz Women’s Hospital, New Hyde Park, N.Y., said that the results are “not at all surprising.” Dr. Hippolyte was not involved in the research.

“We do know that PCOS is and should be treated as a metabolic syndrome. It’s a lot more than just infertility or changes or abnormalities with one’s menstrual cycle. It impacts a woman’s risk for diabetes, prediabetes, and abnormal lipid profile, regardless of whether or not she is obese,” said Dr. Hippolyte.

She agrees with the need for specialized clinics to help such vulnerable patients manage their weight.

“It would be great if insurances would cover things like nutritional counseling or have nutritionists on their roster so that patients can easily access that service. Many patients want to do right, especially preconceptually, but it is difficult without having access to resources. Unfortunately, as clinicians, we’re not as well versed in nutrition as we would like to be or should be, so we need a multidisciplinary approach. We need nutrition and weight loss clinics and proper services to really help these patients.”

The study was supported by the Canadian Institute of Health Research and ICES. Dr. Velez and Dr. Hippolyte reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Polycystic ovary syndrome (PCOS) is associated with an increased risk of gestational diabetes, but this risk is heightened significantly in the presence of obesity, according to new research.

In a population-based cohort study that included more than 1.2 million hospital live births, PCOS was associated with a 5% increase in risk for gestational diabetes. Almost 90% of this association was mediated by obesity.

“Women with PCOS are at higher risk, but it’s only 5% higher than the general population. However, that risk rises substantially with obesity,” senior author Maria P. Velez, MD, PhD, clinician-scientist and associate professor of obstetrics and gynecology at Queen’s University, Kingston, Ont., said in an interview. “Our study highlights the need for counseling our patients about the importance of weight optimization, ideally starting with lifestyle changes like diet and exercise.”The findings were published  in the Journal of Obstetrics and Gynaecology Canada.
 

Major mediator

The estimated prevalence of PCOS is 8%-13%, and affected patients often present with anovulation, hyperandrogenism, obesity, metabolic syndrome, and infertility. Prepregnancy insulin resistance is common among women with PCOS and may play a major part in the pathogenesis of gestational diabetes. In addition, PCOS is often accompanied by excess weight gain; about 60% of women with PCOS are overweight or obese.

Previous research has shown that PCOS is a risk factor for gestational diabetes independent of obesity, while other research has shown that obesity has an important effect on this risk.

For the current study, the researchers used causal mediation analysis to elucidate more clearly the effect of obesity on the development of gestational diabetes among patients with PCOS. No previous study has used causal mediation analysis to examine this relationship.

Using data from linked universal health databases in Ontario, the researchers analyzed data on 1,268,901 births between 2006 and 2018. Of these births, 386,748 were associated with maternal PCOS.

The rate of gestational diabetes was higher among women with PCOS (60.2 per 1000 births), compared with women without PCOS (48.6 per 1,000 births). The finding resulted in an adjusted relative risk of 1.05. Obesity mediated 89.7% of this association.

“We hope that these data will inform preconception counseling and gestational diabetes screening in pregnant women with PCOS,” said Dr. Velez. “We have the data now to counsel our patients on the importance of weight management before pregnancy. But we need more resources, such as specialized clinics, to help these patients cope with managing their weight. We can tell our patients to work on their weight management, but they need much more support from the health care system.”
 

Results ‘not surprising’

Commenting on the study, Francine Hippolyte, MD, vice chair of obstetrics and gynecology at Long Island Jewish Medical Center, Katz Women’s Hospital, New Hyde Park, N.Y., said that the results are “not at all surprising.” Dr. Hippolyte was not involved in the research.

“We do know that PCOS is and should be treated as a metabolic syndrome. It’s a lot more than just infertility or changes or abnormalities with one’s menstrual cycle. It impacts a woman’s risk for diabetes, prediabetes, and abnormal lipid profile, regardless of whether or not she is obese,” said Dr. Hippolyte.

She agrees with the need for specialized clinics to help such vulnerable patients manage their weight.

“It would be great if insurances would cover things like nutritional counseling or have nutritionists on their roster so that patients can easily access that service. Many patients want to do right, especially preconceptually, but it is difficult without having access to resources. Unfortunately, as clinicians, we’re not as well versed in nutrition as we would like to be or should be, so we need a multidisciplinary approach. We need nutrition and weight loss clinics and proper services to really help these patients.”

The study was supported by the Canadian Institute of Health Research and ICES. Dr. Velez and Dr. Hippolyte reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Polycystic ovary syndrome (PCOS) is associated with an increased risk of gestational diabetes, but this risk is heightened significantly in the presence of obesity, according to new research.

In a population-based cohort study that included more than 1.2 million hospital live births, PCOS was associated with a 5% increase in risk for gestational diabetes. Almost 90% of this association was mediated by obesity.

“Women with PCOS are at higher risk, but it’s only 5% higher than the general population. However, that risk rises substantially with obesity,” senior author Maria P. Velez, MD, PhD, clinician-scientist and associate professor of obstetrics and gynecology at Queen’s University, Kingston, Ont., said in an interview. “Our study highlights the need for counseling our patients about the importance of weight optimization, ideally starting with lifestyle changes like diet and exercise.”The findings were published  in the Journal of Obstetrics and Gynaecology Canada.
 

Major mediator

The estimated prevalence of PCOS is 8%-13%, and affected patients often present with anovulation, hyperandrogenism, obesity, metabolic syndrome, and infertility. Prepregnancy insulin resistance is common among women with PCOS and may play a major part in the pathogenesis of gestational diabetes. In addition, PCOS is often accompanied by excess weight gain; about 60% of women with PCOS are overweight or obese.

Previous research has shown that PCOS is a risk factor for gestational diabetes independent of obesity, while other research has shown that obesity has an important effect on this risk.

For the current study, the researchers used causal mediation analysis to elucidate more clearly the effect of obesity on the development of gestational diabetes among patients with PCOS. No previous study has used causal mediation analysis to examine this relationship.

Using data from linked universal health databases in Ontario, the researchers analyzed data on 1,268,901 births between 2006 and 2018. Of these births, 386,748 were associated with maternal PCOS.

The rate of gestational diabetes was higher among women with PCOS (60.2 per 1000 births), compared with women without PCOS (48.6 per 1,000 births). The finding resulted in an adjusted relative risk of 1.05. Obesity mediated 89.7% of this association.

“We hope that these data will inform preconception counseling and gestational diabetes screening in pregnant women with PCOS,” said Dr. Velez. “We have the data now to counsel our patients on the importance of weight management before pregnancy. But we need more resources, such as specialized clinics, to help these patients cope with managing their weight. We can tell our patients to work on their weight management, but they need much more support from the health care system.”
 

Results ‘not surprising’

Commenting on the study, Francine Hippolyte, MD, vice chair of obstetrics and gynecology at Long Island Jewish Medical Center, Katz Women’s Hospital, New Hyde Park, N.Y., said that the results are “not at all surprising.” Dr. Hippolyte was not involved in the research.

“We do know that PCOS is and should be treated as a metabolic syndrome. It’s a lot more than just infertility or changes or abnormalities with one’s menstrual cycle. It impacts a woman’s risk for diabetes, prediabetes, and abnormal lipid profile, regardless of whether or not she is obese,” said Dr. Hippolyte.

She agrees with the need for specialized clinics to help such vulnerable patients manage their weight.

“It would be great if insurances would cover things like nutritional counseling or have nutritionists on their roster so that patients can easily access that service. Many patients want to do right, especially preconceptually, but it is difficult without having access to resources. Unfortunately, as clinicians, we’re not as well versed in nutrition as we would like to be or should be, so we need a multidisciplinary approach. We need nutrition and weight loss clinics and proper services to really help these patients.”

The study was supported by the Canadian Institute of Health Research and ICES. Dr. Velez and Dr. Hippolyte reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

TOPLINE:

Among the 3,188 people with type 2 diabetes who were adherent to their tirzepatide (Mounjaro, Lilly) regimen in four pivotal trials of the agent, a quarter achieved at least a 15% cut from their baseline body weight after 40-42 weeks of treatment, and researchers found seven baseline variables that were significantly linked with a higher incidence of this level of weight loss.

“These findings help inform which people with type 2 diabetes are most likely to achieve greater body weight reduction with improved cardiometabolic risk factors with tirzepatide,” say the authors.

METHODOLOGY:

• Investigators conducted a post hoc analysis of data collected from a total of 3,188 people with type 2 diabetes who had been adherent to their assigned tirzepatide regimen for 40-42 weeks in any one of four pivotal trials of the agent.
• The researchers aimed to identify predictors of a reduction in body weight of at least 15% with tirzepatide treatment at any of the three tested doses – 5 mg, 10 mg, or 15 mg – which were administered by subcutaneous injection once a week.
• All four trials that provided data prohibited concurrent therapy that would promote weight loss, and the people included in the analysis did not receive any rescue medications for controlling glycemia.
• The primary efficacy measure in all four studies was the ability of tirzepatide to improve glycemic control (measured by A1c level), compared with placebo, semaglutide (Ozempic) 1 mg SC once weekly, insulin degludec (Tresiba, Novo Nordisk), or insulin glargine (Basaglar, Lilly).

TAKEAWAY:

• Among the 3,188 people who remained adherent to their tirzepatide regimen for 40-42 weeks, 792 (25%) experienced a weight reduction of at least 15% from baseline.
• Multivariate analysis of baseline covariates showed that these seven factors were significantly linked with greater than or equal to 15% weight loss: higher tirzepatide dose, being female, being of White or Asian race, being of younger age, undergoing treatment with metformin, having better glycemic control (based on lower A1c and lower fasting serum glucose), and having lower non–high-density lipoprotein cholesterol level.
• During follow-up, achievement of at least a 15% cut in baseline body weight was significantly associated with greater reductions in A1c, fasting serum glucose level, waist circumference, blood pressure, serum triglyceride level, and serum level of the liver enzyme alanine transaminase.

IN PRACTICE:

“These findings may provide valuable information to clinicians and people with type 2 diabetes regarding the likelihood of achieving substantial body weight reduction with tirzepatide and also help to signal likely improvements to be seen in a range of cardiometabolic risk parameters with tirzepatide-induced weight loss,” the authors concluded in their report.

SOURCE:

The study was largely run by researchers who are employees of Lilly, the company that markets tirzepatide (Mounjaro). It was published in Diabetes Care.

LIMITATIONS:

• The analysis was post hoc.
• The follow-up was limited.
• The analysis focused entirely on baseline parameters as potential predictors of weight loss magnitude.

DISCLOSURES:

The study was funded by Eli Lilly, the company that markets tirzepatide (Mounjaro) and that sponsored the SURPASS trials. Six authors are employees of Lilly, one is a contractor for Lilly, and the two remaining authors have had financial relationships with Lilly and with several other companies.

A version of this article first appeared on Medscape.com.

TOPLINE:

Among the 3,188 people with type 2 diabetes who were adherent to their tirzepatide (Mounjaro, Lilly) regimen in four pivotal trials of the agent, a quarter achieved at least a 15% cut from their baseline body weight after 40-42 weeks of treatment, and researchers found seven baseline variables that were significantly linked with a higher incidence of this level of weight loss.

“These findings help inform which people with type 2 diabetes are most likely to achieve greater body weight reduction with improved cardiometabolic risk factors with tirzepatide,” say the authors.

METHODOLOGY:

• Investigators conducted a post hoc analysis of data collected from a total of 3,188 people with type 2 diabetes who had been adherent to their assigned tirzepatide regimen for 40-42 weeks in any one of four pivotal trials of the agent.
• The researchers aimed to identify predictors of a reduction in body weight of at least 15% with tirzepatide treatment at any of the three tested doses – 5 mg, 10 mg, or 15 mg – which were administered by subcutaneous injection once a week.
• All four trials that provided data prohibited concurrent therapy that would promote weight loss, and the people included in the analysis did not receive any rescue medications for controlling glycemia.
• The primary efficacy measure in all four studies was the ability of tirzepatide to improve glycemic control (measured by A1c level), compared with placebo, semaglutide (Ozempic) 1 mg SC once weekly, insulin degludec (Tresiba, Novo Nordisk), or insulin glargine (Basaglar, Lilly).

TAKEAWAY:

• Among the 3,188 people who remained adherent to their tirzepatide regimen for 40-42 weeks, 792 (25%) experienced a weight reduction of at least 15% from baseline.
• Multivariate analysis of baseline covariates showed that these seven factors were significantly linked with greater than or equal to 15% weight loss: higher tirzepatide dose, being female, being of White or Asian race, being of younger age, undergoing treatment with metformin, having better glycemic control (based on lower A1c and lower fasting serum glucose), and having lower non–high-density lipoprotein cholesterol level.
• During follow-up, achievement of at least a 15% cut in baseline body weight was significantly associated with greater reductions in A1c, fasting serum glucose level, waist circumference, blood pressure, serum triglyceride level, and serum level of the liver enzyme alanine transaminase.

IN PRACTICE:

“These findings may provide valuable information to clinicians and people with type 2 diabetes regarding the likelihood of achieving substantial body weight reduction with tirzepatide and also help to signal likely improvements to be seen in a range of cardiometabolic risk parameters with tirzepatide-induced weight loss,” the authors concluded in their report.

SOURCE:

The study was largely run by researchers who are employees of Lilly, the company that markets tirzepatide (Mounjaro). It was published in Diabetes Care.

LIMITATIONS:

• The analysis was post hoc.
• The follow-up was limited.
• The analysis focused entirely on baseline parameters as potential predictors of weight loss magnitude.

DISCLOSURES:

The study was funded by Eli Lilly, the company that markets tirzepatide (Mounjaro) and that sponsored the SURPASS trials. Six authors are employees of Lilly, one is a contractor for Lilly, and the two remaining authors have had financial relationships with Lilly and with several other companies.

A version of this article first appeared on Medscape.com.

TOPLINE:

Among the 3,188 people with type 2 diabetes who were adherent to their tirzepatide (Mounjaro, Lilly) regimen in four pivotal trials of the agent, a quarter achieved at least a 15% cut from their baseline body weight after 40-42 weeks of treatment, and researchers found seven baseline variables that were significantly linked with a higher incidence of this level of weight loss.

“These findings help inform which people with type 2 diabetes are most likely to achieve greater body weight reduction with improved cardiometabolic risk factors with tirzepatide,” say the authors.

METHODOLOGY:

• Investigators conducted a post hoc analysis of data collected from a total of 3,188 people with type 2 diabetes who had been adherent to their assigned tirzepatide regimen for 40-42 weeks in any one of four pivotal trials of the agent.
• The researchers aimed to identify predictors of a reduction in body weight of at least 15% with tirzepatide treatment at any of the three tested doses – 5 mg, 10 mg, or 15 mg – which were administered by subcutaneous injection once a week.
• All four trials that provided data prohibited concurrent therapy that would promote weight loss, and the people included in the analysis did not receive any rescue medications for controlling glycemia.
• The primary efficacy measure in all four studies was the ability of tirzepatide to improve glycemic control (measured by A1c level), compared with placebo, semaglutide (Ozempic) 1 mg SC once weekly, insulin degludec (Tresiba, Novo Nordisk), or insulin glargine (Basaglar, Lilly).

TAKEAWAY:

• Among the 3,188 people who remained adherent to their tirzepatide regimen for 40-42 weeks, 792 (25%) experienced a weight reduction of at least 15% from baseline.
• Multivariate analysis of baseline covariates showed that these seven factors were significantly linked with greater than or equal to 15% weight loss: higher tirzepatide dose, being female, being of White or Asian race, being of younger age, undergoing treatment with metformin, having better glycemic control (based on lower A1c and lower fasting serum glucose), and having lower non–high-density lipoprotein cholesterol level.
• During follow-up, achievement of at least a 15% cut in baseline body weight was significantly associated with greater reductions in A1c, fasting serum glucose level, waist circumference, blood pressure, serum triglyceride level, and serum level of the liver enzyme alanine transaminase.

IN PRACTICE:

“These findings may provide valuable information to clinicians and people with type 2 diabetes regarding the likelihood of achieving substantial body weight reduction with tirzepatide and also help to signal likely improvements to be seen in a range of cardiometabolic risk parameters with tirzepatide-induced weight loss,” the authors concluded in their report.

SOURCE:

The study was largely run by researchers who are employees of Lilly, the company that markets tirzepatide (Mounjaro). It was published in Diabetes Care.

LIMITATIONS:

• The analysis was post hoc.
• The follow-up was limited.
• The analysis focused entirely on baseline parameters as potential predictors of weight loss magnitude.

DISCLOSURES:

The study was funded by Eli Lilly, the company that markets tirzepatide (Mounjaro) and that sponsored the SURPASS trials. Six authors are employees of Lilly, one is a contractor for Lilly, and the two remaining authors have had financial relationships with Lilly and with several other companies.

A version of this article first appeared on Medscape.com.

VANCOUVER – Patients who undergo either Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy are at an increased risk of fracture, compared with patients with obesity who do not undergo surgery, according to a new analysis of a predominantly male group of U.S. veterans.

Previous studies involving premenopausal women have found a risk of bone mineral density loss and fracture with bariatric surgery, but little was known about the risk among men. Research has also shown an increase in risk after RYGB, but there is less information on risks associated with sleeve gastrectomy, though it is now the most common surgery for weight loss.

Bone density loss after bariatric surgery has been shown to be significant, according to Eileen H. Koh, MD. “It’s quite a lot of bone loss, quickly,” said Dr. Koh, a graduated fellow from the endocrinology program at the University of California, San Francisco, who is moving to the University of Washington, Seattle.

Those observations generally come from studies of younger women. The purpose of the new study “was to see if we see the same risk of fracture in veterans who are older men, so kind of the opposite of the typical bariatric patient,” said Dr. Koh, who presented the research at the annual meeting of the American Society for Bone and Mineral Research.

The researchers analyzed data from 8,299 U.S. veterans who underwent sleeve gastrectomy (41%), RYGB (51%), adjustable gastric banding (4%), or an unspecified bariatric procedure (4%) between 2000 and 2020. They were matched with 24,877 individuals with obesity who did not undergo surgery. The investigators excluded individuals who were at high risk of fracture because of another condition, such as organ transplantation or dialysis. Men made up 70% of both surgical and nonsurgical groups. The mean age was 52 years for both, and 89% and 88% were not Hispanic or Latino, respectively. The proportion of White individuals was 72% and 64%, and the proportion of Black individuals was 18% and 24%.

After adjustment for demographic variables and comorbidities, bariatric surgery was associated with a 68% increased risk of fracture (hazard ratio, 1.68; 95% confidence interval, 1.57-1.80), including hip fractures (HR, 2.42; 95% CI, 1.98-2.97), spine (HR, 1.82; 95% CI, 1.61-2.06), radius/ulna (HR, 2.38; 95% CI, 2.05-2.77), humerus (HR, 1.56; 95% CI, 1.28-1.89), pelvis (HR, 2.41; 95% CI, 1.68-3.46), and tibia/fibula/ankle (HR, 1.50; 95% CI, 1.33-1.69). Increased fracture risk was associated with RYGB (HR, 1.93; 95% CI, 1.75-2.12) and sleeve gastrectomy (HR, 1.50; 95% CI, 1.33-1.69) but not adjustable gastric banding.

Compared with sleeve gastrectomy, adjustable gastric banding was associated with a decreased risk of fracture (HR, 0.64; 95% CI, 0.49-0.84; P = .0012).

The study’s predominantly male population is important because men also get osteoporosis and are frequently overlooked, according to Anne Schafer, MD, who was the lead author of the study. “Even after they fracture, men are sometimes less likely to get care to prevent the next fracture. We’ve shown here that especially men who are on the older side, who go through surgical weight loss, do have a higher risk of fracture compared to those who are similarly obese but have not had the operation,” said Dr. Schafer, a professor of medicine at the University of California, San Francisco, and chief of endocrinology and metabolism at the San Francisco VA Medical Center.

There are limited data on fracture risk after sleeve gastrectomy. “I think this is one of the first times that I’ve been able to demonstrate that there was a higher risk of fracture with sleeve gastrectomy in comparison with nonsurgical cohorts. Of course, it’s necessary to confirm these findings in further studies, but it’s interesting,” said Julien Paccou, MD, who attended the poster session and was asked for comment. His group’s study of a French population showed an increased fracture risk associated with RYGB but not sleeve gastrectomy. Another study found a reduction of fracture risk associated with sleeve gastrectomy and no difference between RYGB and nonsurgical matched control patients in a Medicare population.

In fact, there is a belief that fracture risk may be lower with sleeve gastrectomy, according to Dr. Schafer. “It’s part of why it’s so popular,” she said.

The reasons for increased fracture risk following surgical weight loss remains unknown, according to Dr. Paccou, but they could include mechanical unloading, loss of lean mass, and hormone and nutrition changes. “There are many, many factors,” said Dr. Paccou, a professor of rheumatology at Hospital Roger Salengro in Lille, France.

The study’s findings of increased risk of fracture after sleeve gastrectomy may be an argument against malabsorption because the procedure shouldn’t affect nutrient absorption. It suggests that other factors are at play. “It’s not the only reason,” Dr. Schafer said.

There are recommendations for postbariatric surgery care to optimize bone health, such as protein intake and calcium and vitamin D targets, along with lifestyle factors. “Despite all those [efforts], we still know that bone loss occurs,” Dr. Koh said. In fact, the group is conducting a study funded by Amgen of the use of denosumab (Prolia) for the prevention of high-turnover bone loss after RYGB and sleeve gastrectomy.

Dr. Schafer has received research support from Bone Health Technologies and Amgen. Dr. Koh and Dr. Paccou have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

VANCOUVER – Patients who undergo either Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy are at an increased risk of fracture, compared with patients with obesity who do not undergo surgery, according to a new analysis of a predominantly male group of U.S. veterans.

Previous studies involving premenopausal women have found a risk of bone mineral density loss and fracture with bariatric surgery, but little was known about the risk among men. Research has also shown an increase in risk after RYGB, but there is less information on risks associated with sleeve gastrectomy, though it is now the most common surgery for weight loss.

Bone density loss after bariatric surgery has been shown to be significant, according to Eileen H. Koh, MD. “It’s quite a lot of bone loss, quickly,” said Dr. Koh, a graduated fellow from the endocrinology program at the University of California, San Francisco, who is moving to the University of Washington, Seattle.

Those observations generally come from studies of younger women. The purpose of the new study “was to see if we see the same risk of fracture in veterans who are older men, so kind of the opposite of the typical bariatric patient,” said Dr. Koh, who presented the research at the annual meeting of the American Society for Bone and Mineral Research.

The researchers analyzed data from 8,299 U.S. veterans who underwent sleeve gastrectomy (41%), RYGB (51%), adjustable gastric banding (4%), or an unspecified bariatric procedure (4%) between 2000 and 2020. They were matched with 24,877 individuals with obesity who did not undergo surgery. The investigators excluded individuals who were at high risk of fracture because of another condition, such as organ transplantation or dialysis. Men made up 70% of both surgical and nonsurgical groups. The mean age was 52 years for both, and 89% and 88% were not Hispanic or Latino, respectively. The proportion of White individuals was 72% and 64%, and the proportion of Black individuals was 18% and 24%.

After adjustment for demographic variables and comorbidities, bariatric surgery was associated with a 68% increased risk of fracture (hazard ratio, 1.68; 95% confidence interval, 1.57-1.80), including hip fractures (HR, 2.42; 95% CI, 1.98-2.97), spine (HR, 1.82; 95% CI, 1.61-2.06), radius/ulna (HR, 2.38; 95% CI, 2.05-2.77), humerus (HR, 1.56; 95% CI, 1.28-1.89), pelvis (HR, 2.41; 95% CI, 1.68-3.46), and tibia/fibula/ankle (HR, 1.50; 95% CI, 1.33-1.69). Increased fracture risk was associated with RYGB (HR, 1.93; 95% CI, 1.75-2.12) and sleeve gastrectomy (HR, 1.50; 95% CI, 1.33-1.69) but not adjustable gastric banding.

Compared with sleeve gastrectomy, adjustable gastric banding was associated with a decreased risk of fracture (HR, 0.64; 95% CI, 0.49-0.84; P = .0012).

The study’s predominantly male population is important because men also get osteoporosis and are frequently overlooked, according to Anne Schafer, MD, who was the lead author of the study. “Even after they fracture, men are sometimes less likely to get care to prevent the next fracture. We’ve shown here that especially men who are on the older side, who go through surgical weight loss, do have a higher risk of fracture compared to those who are similarly obese but have not had the operation,” said Dr. Schafer, a professor of medicine at the University of California, San Francisco, and chief of endocrinology and metabolism at the San Francisco VA Medical Center.

There are limited data on fracture risk after sleeve gastrectomy. “I think this is one of the first times that I’ve been able to demonstrate that there was a higher risk of fracture with sleeve gastrectomy in comparison with nonsurgical cohorts. Of course, it’s necessary to confirm these findings in further studies, but it’s interesting,” said Julien Paccou, MD, who attended the poster session and was asked for comment. His group’s study of a French population showed an increased fracture risk associated with RYGB but not sleeve gastrectomy. Another study found a reduction of fracture risk associated with sleeve gastrectomy and no difference between RYGB and nonsurgical matched control patients in a Medicare population.

In fact, there is a belief that fracture risk may be lower with sleeve gastrectomy, according to Dr. Schafer. “It’s part of why it’s so popular,” she said.

The reasons for increased fracture risk following surgical weight loss remains unknown, according to Dr. Paccou, but they could include mechanical unloading, loss of lean mass, and hormone and nutrition changes. “There are many, many factors,” said Dr. Paccou, a professor of rheumatology at Hospital Roger Salengro in Lille, France.

The study’s findings of increased risk of fracture after sleeve gastrectomy may be an argument against malabsorption because the procedure shouldn’t affect nutrient absorption. It suggests that other factors are at play. “It’s not the only reason,” Dr. Schafer said.

There are recommendations for postbariatric surgery care to optimize bone health, such as protein intake and calcium and vitamin D targets, along with lifestyle factors. “Despite all those [efforts], we still know that bone loss occurs,” Dr. Koh said. In fact, the group is conducting a study funded by Amgen of the use of denosumab (Prolia) for the prevention of high-turnover bone loss after RYGB and sleeve gastrectomy.

Dr. Schafer has received research support from Bone Health Technologies and Amgen. Dr. Koh and Dr. Paccou have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

VANCOUVER – Patients who undergo either Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy are at an increased risk of fracture, compared with patients with obesity who do not undergo surgery, according to a new analysis of a predominantly male group of U.S. veterans.

Previous studies involving premenopausal women have found a risk of bone mineral density loss and fracture with bariatric surgery, but little was known about the risk among men. Research has also shown an increase in risk after RYGB, but there is less information on risks associated with sleeve gastrectomy, though it is now the most common surgery for weight loss.

Bone density loss after bariatric surgery has been shown to be significant, according to Eileen H. Koh, MD. “It’s quite a lot of bone loss, quickly,” said Dr. Koh, a graduated fellow from the endocrinology program at the University of California, San Francisco, who is moving to the University of Washington, Seattle.

Those observations generally come from studies of younger women. The purpose of the new study “was to see if we see the same risk of fracture in veterans who are older men, so kind of the opposite of the typical bariatric patient,” said Dr. Koh, who presented the research at the annual meeting of the American Society for Bone and Mineral Research.

The researchers analyzed data from 8,299 U.S. veterans who underwent sleeve gastrectomy (41%), RYGB (51%), adjustable gastric banding (4%), or an unspecified bariatric procedure (4%) between 2000 and 2020. They were matched with 24,877 individuals with obesity who did not undergo surgery. The investigators excluded individuals who were at high risk of fracture because of another condition, such as organ transplantation or dialysis. Men made up 70% of both surgical and nonsurgical groups. The mean age was 52 years for both, and 89% and 88% were not Hispanic or Latino, respectively. The proportion of White individuals was 72% and 64%, and the proportion of Black individuals was 18% and 24%.

After adjustment for demographic variables and comorbidities, bariatric surgery was associated with a 68% increased risk of fracture (hazard ratio, 1.68; 95% confidence interval, 1.57-1.80), including hip fractures (HR, 2.42; 95% CI, 1.98-2.97), spine (HR, 1.82; 95% CI, 1.61-2.06), radius/ulna (HR, 2.38; 95% CI, 2.05-2.77), humerus (HR, 1.56; 95% CI, 1.28-1.89), pelvis (HR, 2.41; 95% CI, 1.68-3.46), and tibia/fibula/ankle (HR, 1.50; 95% CI, 1.33-1.69). Increased fracture risk was associated with RYGB (HR, 1.93; 95% CI, 1.75-2.12) and sleeve gastrectomy (HR, 1.50; 95% CI, 1.33-1.69) but not adjustable gastric banding.

Compared with sleeve gastrectomy, adjustable gastric banding was associated with a decreased risk of fracture (HR, 0.64; 95% CI, 0.49-0.84; P = .0012).

The study’s predominantly male population is important because men also get osteoporosis and are frequently overlooked, according to Anne Schafer, MD, who was the lead author of the study. “Even after they fracture, men are sometimes less likely to get care to prevent the next fracture. We’ve shown here that especially men who are on the older side, who go through surgical weight loss, do have a higher risk of fracture compared to those who are similarly obese but have not had the operation,” said Dr. Schafer, a professor of medicine at the University of California, San Francisco, and chief of endocrinology and metabolism at the San Francisco VA Medical Center.

There are limited data on fracture risk after sleeve gastrectomy. “I think this is one of the first times that I’ve been able to demonstrate that there was a higher risk of fracture with sleeve gastrectomy in comparison with nonsurgical cohorts. Of course, it’s necessary to confirm these findings in further studies, but it’s interesting,” said Julien Paccou, MD, who attended the poster session and was asked for comment. His group’s study of a French population showed an increased fracture risk associated with RYGB but not sleeve gastrectomy. Another study found a reduction of fracture risk associated with sleeve gastrectomy and no difference between RYGB and nonsurgical matched control patients in a Medicare population.

In fact, there is a belief that fracture risk may be lower with sleeve gastrectomy, according to Dr. Schafer. “It’s part of why it’s so popular,” she said.

The reasons for increased fracture risk following surgical weight loss remains unknown, according to Dr. Paccou, but they could include mechanical unloading, loss of lean mass, and hormone and nutrition changes. “There are many, many factors,” said Dr. Paccou, a professor of rheumatology at Hospital Roger Salengro in Lille, France.

The study’s findings of increased risk of fracture after sleeve gastrectomy may be an argument against malabsorption because the procedure shouldn’t affect nutrient absorption. It suggests that other factors are at play. “It’s not the only reason,” Dr. Schafer said.

There are recommendations for postbariatric surgery care to optimize bone health, such as protein intake and calcium and vitamin D targets, along with lifestyle factors. “Despite all those [efforts], we still know that bone loss occurs,” Dr. Koh said. In fact, the group is conducting a study funded by Amgen of the use of denosumab (Prolia) for the prevention of high-turnover bone loss after RYGB and sleeve gastrectomy.

Dr. Schafer has received research support from Bone Health Technologies and Amgen. Dr. Koh and Dr. Paccou have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

DALLAS – Researchers identified behavioral, psychological, and environmental predictors of continued weight loss maintenance vs. weight regain in a large cohort of members of WeightWatchers who had successful long-term weight loss.

On average, the participants had lost 25.5 kg (56 lb) and kept it off for 3.5 years, when they entered the 1-year study.

At study entry and 1 year later, the participants replied to several questionnaires that asked about predictors of weight loss maintenance.

Compared with people who gained weight over the 1-year study, those who maintained their weight within 2.3 kg (5 lb) reported more consistent monitoring of their diet and weight and greater acceptance of uncomfortable food cravings.

They also had reduced disinhibition (tendency to overeat) when faced with food cues, as well as less pain and a more positive body image “at any weight, shape, or size,” Suzanne Phelan, MD, PhD, reported.

Dr. Phelan, from the department of kinesiology and public health, California Polytechnic State University, San Luis Obispo, presented the study in an Obesity symposium at the annual meeting of the Obesity Society, and it was simultaneously published in the journal. The study was selected as one of five top papers submitted to the journal to coincide with the meeting.

Future interventions to prevent weight regain should target overeating in response to internal and external food cues and declines in self-monitoring and body image, Dr. Phelan said.

The study aimed to identify behaviors that might predict who might “beat the odds” and sustain long-term weight loss, she said in an interview.

The findings suggest that the people who maintained their weight loss had developed skills to help them cope with cravings and not respond by eating, she said. Continued self-monitoring and body acceptance and appreciation (all body sizes are beautiful) were key elements of successful weight-loss maintenance.
 

No antiobesity drugs or surgery; don’t forget behavioral stuff

Importantly, although 43% of the study participants regained more than five pounds during this 1-year study, they still remained at 18% below their starting weight, “indicating that they were largely successful at weight loss,” Dr. Phelan said.

Michael D. Jensen, MD, editor-in-chief of Obesity, echoed this.

The researchers “did find some weak predictors of success,” said Dr. Jensen, from Mayo Clinic, Rochester, Minn. “But perhaps as important,” he said, “was that at the end of the trial, even those who had regained some slight weight still had 18% weight loss – which is not trivial – after, on average, 4.5 years with a standard commercial weight management program.

“At every talk I go to here,” the message is, “Let’s stampede towards use of the drugs and skip diet and exercise and behavioral stuff,” he observed. “I would argue,” he said, “that when it works, it works really well, and it’s free. So this idea that we shouldn’t even try it, because we know it’s going to fail, is wrong.

“If you have the right group, they have a decent chance of having a sufficiently good response that you don’t have to give the medications and you don’t have to send them for bariatric surgery.

“Once you learn from these programs what to do, you’re not paying $1,000 a month for a drug and you haven’t had bariatric surgery,” Dr. Jensen noted. “Their 3 years of follow-up of WeightWatchers cost less than 1 month worth of one of these [antiobesity medications].”

The predictive findings were like ‘”icing on the cake,” he said. Anybody can find five people who’ve done well with therapy, but this study was in more than 2,800 people who did well with a commercial program that is not expensive.
 

Study design and findings

Between 2019 and 2020, WeightWatchers invited adult members who had maintained weight loss of at least 9.1 kg (20 lb) for at least 1 year to participate in this study.

Of 7,025 participants who entered the study, 4,004 individuals (57%) who did not complete the 1-year questionnaires and others with implausible weight were excluded, leaving a final sample of 2,843 participants.

Most participants were women (92%), non-Hispanic White (95%), married (92%), and college educated. They had a mean age of 56 years.

On average, the participants had a body mass index (BMI) of 35.9 kg/m² (grade 2 obesity) at the start of the WeightWatchers program and a BMI of 26.7 when they entered the current study.

At the 1-year follow-up, 57% of the participants had maintained the same weight (within 2.3 kg) as when they enrolled in the study, and 43% had gained ≥ 2.3 kg.

On average, the weight-loss maintainers had gained 0.4 kg (0.88 lb). The weight gainers had gained 7.2 kg (15.9 lb) but were still 19.1 kg (42.1 lb) below the weight they had when they started the WeightWatchers program.

At baseline, compared with the weight gainers, the weight-loss maintainers were on average older (58 vs. 52 years), had a lower initial BMI (26 vs. 28), and had longer duration of weight loss maintenance (4 vs. 3 years).

At 1 year, those who had maintained their weight loss had greater self-monitoring, psychological coping, physical activity strategies, dietary choice strategies, and eating and physical activity habits, and they had less eating initiation in the absence of hunger.

They also had less disinhibition, more willingness to ignore cravings and accept food urges, more future orientation, more mindfulness, more positive body image and body satisfaction, better general health and mental health, and less bodily pain.

This research was supported by a grant to Dr. Phelan from WeightWatchers (WW) International, and three study authors are employees and shareholders of the company. Dr. Jensen discloses consulting for Biohaven Pharmaceuticals and for Seattle Gummy Co.

A version of this article first appeared on Medscape.com.

DALLAS – Researchers identified behavioral, psychological, and environmental predictors of continued weight loss maintenance vs. weight regain in a large cohort of members of WeightWatchers who had successful long-term weight loss.

On average, the participants had lost 25.5 kg (56 lb) and kept it off for 3.5 years, when they entered the 1-year study.

At study entry and 1 year later, the participants replied to several questionnaires that asked about predictors of weight loss maintenance.

Compared with people who gained weight over the 1-year study, those who maintained their weight within 2.3 kg (5 lb) reported more consistent monitoring of their diet and weight and greater acceptance of uncomfortable food cravings.

They also had reduced disinhibition (tendency to overeat) when faced with food cues, as well as less pain and a more positive body image “at any weight, shape, or size,” Suzanne Phelan, MD, PhD, reported.

Dr. Phelan, from the department of kinesiology and public health, California Polytechnic State University, San Luis Obispo, presented the study in an Obesity symposium at the annual meeting of the Obesity Society, and it was simultaneously published in the journal. The study was selected as one of five top papers submitted to the journal to coincide with the meeting.

Future interventions to prevent weight regain should target overeating in response to internal and external food cues and declines in self-monitoring and body image, Dr. Phelan said.

The study aimed to identify behaviors that might predict who might “beat the odds” and sustain long-term weight loss, she said in an interview.

The findings suggest that the people who maintained their weight loss had developed skills to help them cope with cravings and not respond by eating, she said. Continued self-monitoring and body acceptance and appreciation (all body sizes are beautiful) were key elements of successful weight-loss maintenance.
 

No antiobesity drugs or surgery; don’t forget behavioral stuff

Importantly, although 43% of the study participants regained more than five pounds during this 1-year study, they still remained at 18% below their starting weight, “indicating that they were largely successful at weight loss,” Dr. Phelan said.

Michael D. Jensen, MD, editor-in-chief of Obesity, echoed this.

The researchers “did find some weak predictors of success,” said Dr. Jensen, from Mayo Clinic, Rochester, Minn. “But perhaps as important,” he said, “was that at the end of the trial, even those who had regained some slight weight still had 18% weight loss – which is not trivial – after, on average, 4.5 years with a standard commercial weight management program.

“At every talk I go to here,” the message is, “Let’s stampede towards use of the drugs and skip diet and exercise and behavioral stuff,” he observed. “I would argue,” he said, “that when it works, it works really well, and it’s free. So this idea that we shouldn’t even try it, because we know it’s going to fail, is wrong.

“If you have the right group, they have a decent chance of having a sufficiently good response that you don’t have to give the medications and you don’t have to send them for bariatric surgery.

“Once you learn from these programs what to do, you’re not paying $1,000 a month for a drug and you haven’t had bariatric surgery,” Dr. Jensen noted. “Their 3 years of follow-up of WeightWatchers cost less than 1 month worth of one of these [antiobesity medications].”

The predictive findings were like ‘”icing on the cake,” he said. Anybody can find five people who’ve done well with therapy, but this study was in more than 2,800 people who did well with a commercial program that is not expensive.
 

Study design and findings

Between 2019 and 2020, WeightWatchers invited adult members who had maintained weight loss of at least 9.1 kg (20 lb) for at least 1 year to participate in this study.

Of 7,025 participants who entered the study, 4,004 individuals (57%) who did not complete the 1-year questionnaires and others with implausible weight were excluded, leaving a final sample of 2,843 participants.

Most participants were women (92%), non-Hispanic White (95%), married (92%), and college educated. They had a mean age of 56 years.

On average, the participants had a body mass index (BMI) of 35.9 kg/m² (grade 2 obesity) at the start of the WeightWatchers program and a BMI of 26.7 when they entered the current study.

At the 1-year follow-up, 57% of the participants had maintained the same weight (within 2.3 kg) as when they enrolled in the study, and 43% had gained ≥ 2.3 kg.

On average, the weight-loss maintainers had gained 0.4 kg (0.88 lb). The weight gainers had gained 7.2 kg (15.9 lb) but were still 19.1 kg (42.1 lb) below the weight they had when they started the WeightWatchers program.

At baseline, compared with the weight gainers, the weight-loss maintainers were on average older (58 vs. 52 years), had a lower initial BMI (26 vs. 28), and had longer duration of weight loss maintenance (4 vs. 3 years).

At 1 year, those who had maintained their weight loss had greater self-monitoring, psychological coping, physical activity strategies, dietary choice strategies, and eating and physical activity habits, and they had less eating initiation in the absence of hunger.

They also had less disinhibition, more willingness to ignore cravings and accept food urges, more future orientation, more mindfulness, more positive body image and body satisfaction, better general health and mental health, and less bodily pain.

This research was supported by a grant to Dr. Phelan from WeightWatchers (WW) International, and three study authors are employees and shareholders of the company. Dr. Jensen discloses consulting for Biohaven Pharmaceuticals and for Seattle Gummy Co.

A version of this article first appeared on Medscape.com.

DALLAS – Researchers identified behavioral, psychological, and environmental predictors of continued weight loss maintenance vs. weight regain in a large cohort of members of WeightWatchers who had successful long-term weight loss.

On average, the participants had lost 25.5 kg (56 lb) and kept it off for 3.5 years, when they entered the 1-year study.

At study entry and 1 year later, the participants replied to several questionnaires that asked about predictors of weight loss maintenance.

Compared with people who gained weight over the 1-year study, those who maintained their weight within 2.3 kg (5 lb) reported more consistent monitoring of their diet and weight and greater acceptance of uncomfortable food cravings.

They also had reduced disinhibition (tendency to overeat) when faced with food cues, as well as less pain and a more positive body image “at any weight, shape, or size,” Suzanne Phelan, MD, PhD, reported.

Dr. Phelan, from the department of kinesiology and public health, California Polytechnic State University, San Luis Obispo, presented the study in an Obesity symposium at the annual meeting of the Obesity Society, and it was simultaneously published in the journal. The study was selected as one of five top papers submitted to the journal to coincide with the meeting.

Future interventions to prevent weight regain should target overeating in response to internal and external food cues and declines in self-monitoring and body image, Dr. Phelan said.

The study aimed to identify behaviors that might predict who might “beat the odds” and sustain long-term weight loss, she said in an interview.

The findings suggest that the people who maintained their weight loss had developed skills to help them cope with cravings and not respond by eating, she said. Continued self-monitoring and body acceptance and appreciation (all body sizes are beautiful) were key elements of successful weight-loss maintenance.
 

No antiobesity drugs or surgery; don’t forget behavioral stuff

Importantly, although 43% of the study participants regained more than five pounds during this 1-year study, they still remained at 18% below their starting weight, “indicating that they were largely successful at weight loss,” Dr. Phelan said.

Michael D. Jensen, MD, editor-in-chief of Obesity, echoed this.

The researchers “did find some weak predictors of success,” said Dr. Jensen, from Mayo Clinic, Rochester, Minn. “But perhaps as important,” he said, “was that at the end of the trial, even those who had regained some slight weight still had 18% weight loss – which is not trivial – after, on average, 4.5 years with a standard commercial weight management program.

“At every talk I go to here,” the message is, “Let’s stampede towards use of the drugs and skip diet and exercise and behavioral stuff,” he observed. “I would argue,” he said, “that when it works, it works really well, and it’s free. So this idea that we shouldn’t even try it, because we know it’s going to fail, is wrong.

“If you have the right group, they have a decent chance of having a sufficiently good response that you don’t have to give the medications and you don’t have to send them for bariatric surgery.

“Once you learn from these programs what to do, you’re not paying $1,000 a month for a drug and you haven’t had bariatric surgery,” Dr. Jensen noted. “Their 3 years of follow-up of WeightWatchers cost less than 1 month worth of one of these [antiobesity medications].”

The predictive findings were like ‘”icing on the cake,” he said. Anybody can find five people who’ve done well with therapy, but this study was in more than 2,800 people who did well with a commercial program that is not expensive.
 

Study design and findings

Between 2019 and 2020, WeightWatchers invited adult members who had maintained weight loss of at least 9.1 kg (20 lb) for at least 1 year to participate in this study.

Of 7,025 participants who entered the study, 4,004 individuals (57%) who did not complete the 1-year questionnaires and others with implausible weight were excluded, leaving a final sample of 2,843 participants.

Most participants were women (92%), non-Hispanic White (95%), married (92%), and college educated. They had a mean age of 56 years.

On average, the participants had a body mass index (BMI) of 35.9 kg/m² (grade 2 obesity) at the start of the WeightWatchers program and a BMI of 26.7 when they entered the current study.

At the 1-year follow-up, 57% of the participants had maintained the same weight (within 2.3 kg) as when they enrolled in the study, and 43% had gained ≥ 2.3 kg.

On average, the weight-loss maintainers had gained 0.4 kg (0.88 lb). The weight gainers had gained 7.2 kg (15.9 lb) but were still 19.1 kg (42.1 lb) below the weight they had when they started the WeightWatchers program.

At baseline, compared with the weight gainers, the weight-loss maintainers were on average older (58 vs. 52 years), had a lower initial BMI (26 vs. 28), and had longer duration of weight loss maintenance (4 vs. 3 years).

At 1 year, those who had maintained their weight loss had greater self-monitoring, psychological coping, physical activity strategies, dietary choice strategies, and eating and physical activity habits, and they had less eating initiation in the absence of hunger.

They also had less disinhibition, more willingness to ignore cravings and accept food urges, more future orientation, more mindfulness, more positive body image and body satisfaction, better general health and mental health, and less bodily pain.

This research was supported by a grant to Dr. Phelan from WeightWatchers (WW) International, and three study authors are employees and shareholders of the company. Dr. Jensen discloses consulting for Biohaven Pharmaceuticals and for Seattle Gummy Co.

A version of this article first appeared on Medscape.com.

TOPLINE:

Endoscopic sleeve gastroplasty (ESG) is safe and effective for weight loss in adults with class I, II, or III obesity, according to real-world data from a large U.S. study.

METHODOLOGY:

• Researchers conducted a retrospective analysis of 1,506 adults (85% female, 70% White) with severe obesity (501 class I, 546 class II, and 459 class III) who underwent ESG at seven academic and private U.S. centers from 2013 to 2022.
• Average percent total body weight loss (%TBWL) was evaluated at 6, 12, 18, and 24 months after the procedure.
• Weight loss and safety outcomes were evaluated according to obesity class.

TAKEAWAY:

• At 12 months, 83.2% of patients achieved ≥10% TBWL and 60.9% achieved ≥15% TBWL across all obesity classes.
• There was a significant difference in TBWL by baseline obesity class, with average weight loss significantly greater in class III than classes I and II at all time points. At 24 months, class III patients had mean TBWL of 20.4%, compared with 13.3% for class I and 13.6% for class II patients.
• As early as 6 months post-ESG, patients in all BMI classes were able to drop to the next lower BMI class and remained there through 2 years. However, ongoing improvement in BMI until the end of follow-up was seen only in class III patients. Notably, class III patients were significantly younger and taller than class I and class II patients.
• There were no differences in adverse events between obesity classes. Only 2.6% of patients had an adverse event requiring hospitalization. Most of these events (86%) were for symptom management and/or fluid replacement.

IN PRACTICE:

“Traditionally, ESG has been proposed as a treatment choice for patients with class I and II obesity because of its modest weight loss outcomes. However, our data show a %TBWL crossing 20% in patients with class III disease, which may push the envelope of perceived utility of ESG,” the authors write.

SOURCE:

The study, with first author Khushboo Gala, MBBS, division of gastroenterology and hepatology, Mayo Clinic, Rochester, Minn., was published online in Clinical and Translational Gastroenterology.

LIMITATIONS:

Limitations include the retrospective design, with outcomes only out to 2 years, and loss of follow-up, with only 339 of the 1506 patients evaluated at 2 years.

DISCLOSURES:

The study had no financial support. Several study authors reported ties to industry. The full list can be found with the original article.

A version of this article first appeared on Medscape.com.

TOPLINE:

Endoscopic sleeve gastroplasty (ESG) is safe and effective for weight loss in adults with class I, II, or III obesity, according to real-world data from a large U.S. study.

METHODOLOGY:

• Researchers conducted a retrospective analysis of 1,506 adults (85% female, 70% White) with severe obesity (501 class I, 546 class II, and 459 class III) who underwent ESG at seven academic and private U.S. centers from 2013 to 2022.
• Average percent total body weight loss (%TBWL) was evaluated at 6, 12, 18, and 24 months after the procedure.
• Weight loss and safety outcomes were evaluated according to obesity class.

TAKEAWAY:

• At 12 months, 83.2% of patients achieved ≥10% TBWL and 60.9% achieved ≥15% TBWL across all obesity classes.
• There was a significant difference in TBWL by baseline obesity class, with average weight loss significantly greater in class III than classes I and II at all time points. At 24 months, class III patients had mean TBWL of 20.4%, compared with 13.3% for class I and 13.6% for class II patients.
• As early as 6 months post-ESG, patients in all BMI classes were able to drop to the next lower BMI class and remained there through 2 years. However, ongoing improvement in BMI until the end of follow-up was seen only in class III patients. Notably, class III patients were significantly younger and taller than class I and class II patients.
• There were no differences in adverse events between obesity classes. Only 2.6% of patients had an adverse event requiring hospitalization. Most of these events (86%) were for symptom management and/or fluid replacement.

IN PRACTICE:

“Traditionally, ESG has been proposed as a treatment choice for patients with class I and II obesity because of its modest weight loss outcomes. However, our data show a %TBWL crossing 20% in patients with class III disease, which may push the envelope of perceived utility of ESG,” the authors write.

SOURCE:

The study, with first author Khushboo Gala, MBBS, division of gastroenterology and hepatology, Mayo Clinic, Rochester, Minn., was published online in Clinical and Translational Gastroenterology.

LIMITATIONS:

Limitations include the retrospective design, with outcomes only out to 2 years, and loss of follow-up, with only 339 of the 1506 patients evaluated at 2 years.

DISCLOSURES:

The study had no financial support. Several study authors reported ties to industry. The full list can be found with the original article.

A version of this article first appeared on Medscape.com.

TOPLINE:

Endoscopic sleeve gastroplasty (ESG) is safe and effective for weight loss in adults with class I, II, or III obesity, according to real-world data from a large U.S. study.

METHODOLOGY:

• Researchers conducted a retrospective analysis of 1,506 adults (85% female, 70% White) with severe obesity (501 class I, 546 class II, and 459 class III) who underwent ESG at seven academic and private U.S. centers from 2013 to 2022.
• Average percent total body weight loss (%TBWL) was evaluated at 6, 12, 18, and 24 months after the procedure.
• Weight loss and safety outcomes were evaluated according to obesity class.

TAKEAWAY:

• At 12 months, 83.2% of patients achieved ≥10% TBWL and 60.9% achieved ≥15% TBWL across all obesity classes.
• There was a significant difference in TBWL by baseline obesity class, with average weight loss significantly greater in class III than classes I and II at all time points. At 24 months, class III patients had mean TBWL of 20.4%, compared with 13.3% for class I and 13.6% for class II patients.
• As early as 6 months post-ESG, patients in all BMI classes were able to drop to the next lower BMI class and remained there through 2 years. However, ongoing improvement in BMI until the end of follow-up was seen only in class III patients. Notably, class III patients were significantly younger and taller than class I and class II patients.
• There were no differences in adverse events between obesity classes. Only 2.6% of patients had an adverse event requiring hospitalization. Most of these events (86%) were for symptom management and/or fluid replacement.

IN PRACTICE:

“Traditionally, ESG has been proposed as a treatment choice for patients with class I and II obesity because of its modest weight loss outcomes. However, our data show a %TBWL crossing 20% in patients with class III disease, which may push the envelope of perceived utility of ESG,” the authors write.

SOURCE:

The study, with first author Khushboo Gala, MBBS, division of gastroenterology and hepatology, Mayo Clinic, Rochester, Minn., was published online in Clinical and Translational Gastroenterology.

LIMITATIONS:

Limitations include the retrospective design, with outcomes only out to 2 years, and loss of follow-up, with only 339 of the 1506 patients evaluated at 2 years.

DISCLOSURES:

The study had no financial support. Several study authors reported ties to industry. The full list can be found with the original article.

A version of this article first appeared on Medscape.com.

Patients with obesity but without major depressive disorder or suicidal ideation within the previous 2 years attained meaningful weight loss with semaglutide, regardless of antidepressant use at baseline, in a post hoc analysis of the Semaglutide Treatment Effect in People with Obesity (STEP) program.

Adverse events, including psychiatric events, were slightly more usual in the patients on antidepressants, Robert Kushner, MD, noted, in an oral session at the annual meeting of the Obesity Society.  

“It is very common that patients who present for weight management are taking antidepressants for various reasons, including depression, anxiety, insomnia, or chronic pain,”Dr. Kushner, from Northwestern University in Chicago, said in an email. “We wanted to see if these participants responded differently to semaglutide, compared to those not on antidepressants.”

“We found that antidepressants do not blunt the effect of semaglutide for weight loss,” he said. “However, there is a slight increase in reported adverse effects.”

“Semaglutide 2.4 mg provides an effective treatment option for weight management, regardless of antidepressant use at baseline,” Dr. Kushner summarized. “Clinicians should be assured that we can use semaglutide in this population of patients.”

Jack Yanovski, MD, PhD, said this was a “great presentation,” noting that “it’s really important that we understand what goes on in patients with depression.”

“Of course, all these trials still had rules that prevent the folks with the most severe depressive symptoms or past suicidality to participate,” added Dr. Yanovski, chief of the Growth and Obesity Section, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Md. “We need specific trials to know exactly how well we do.”

Dr. Kushner agreed, but also noted that, ever since some earlier antidepressants were associated with risk for suicidal ideation and death, strict guidelines were put in place that exclude certain patients from participating in clinical trials.

Dr. Yanovski suggested that now that the drugs are approved, it would be possible to study this, and the information would be important for clinicians.

Dr. Kushner said he hopes that such studies are forthcoming. In the meantime, “data like this will add some support and understanding,” he suggested.
 

36,000 Patients with obesity, 500 on antidepressants

Many people living with obesity report taking antidepressants for depression, anxiety, chronic pain, obsessive-compulsive disorder, sleep disturbance, neuropathy, panic disorder, or posttraumatic stress disorder, Dr. Kushner noted.

However, some of these medications can cause weight gain, and little is known about treatment outcomes for people with obesity who are on antidepressants, since most weight-loss studies exclude people with active major depressive disorder.

The researchers analyzed data from 1,961 patients in STEP 1 and 807 patients in STEP 2 as well as 611 patients in STEP 3 and 304 patients in STEP 5 – 3,683 participants in total, of which 539 were on antidepressants at baseline.

The patients were randomly assigned to 2.4 mg semaglutide vs. placebo plus a lifestyle intervention (STEP 1, 2, and 5) or intensive behavioral therapy (STEP 3 only), for 68 weeks, except STEP 5, which was 104 weeks.

Patients were included if they were aged 18 or older with a body mass index ≥30 kg/m², or ≥27 kg/m² with more than one weight-related complication (STEP 1, 3, and 5) or BMI ≥27 kg/m² with type 2 diabetes (STEP 2 only), and at least one self-reported unsuccessful effort to lose weight by diet.

They were excluded if they had active major depressive disorder within 2 years prior to screening (or other severe psychiatric disorders such as schizophrenia or bipolar disorder) or a Patient Health Questionnaire-9 score of 15 or higher (indicating moderately severe or severe depression), or suicide ideation (type 4 or 5 on the Columbia Suicide Severity Rating Scale) or suicide behavior, within 30 days of screening.

From baseline to week 68, patients on semaglutide (with/without baseline antidepressant use) had a significantly greater change in weight vs. patients on placebo (with/without baseline antidepressant use), respectively:

• STEP 1: –15.7% / –14.7% vs. –0.2% / –2.8%
• STEP 2: –10.7% / –9.5% vs. –3.3% / –3.4%
• STEP 3: –16.2% / –15.9% vs. –5.0% / –5.9%
• STEP 5: –19.0% / –14.1% vs. +1.6% / – 4.0%. 

The proportion of reported adverse events was generally slightly greater in patients receiving semaglutide (with/without baseline antidepressant use) than those on placebo (with/without baseline antidepressant use), respectively:

• STEP 1: 97.7% vs 88.6% and 92.9% vs. 86%
• STEP 2: 97.6% vs 86.5% and 88.6% vs. 77.2%
• STEP 3: 97.6% vs 95.3% and 100% vs. 95.8%
• STEP 5: 100% vs 94.8% and 95.5% vs. 89.2%.

Gastrointestinal adverse events were more frequently reported in the semaglutide group and in patients on antidepressants at baseline. The proportion of patients with psychiatric adverse events was greater in participants on antidepressants at baseline. There were no differences in suicidal ideation/behavior in patients with/without antidepressant use at baseline.

The STEP trials were funded by Novo Nordisk. Dr. Kushner discloses that he served as a consultant for Novo Nordisk, WeightWatchers, Eli Lilly, and Pfizer, and received a research grant from Epitomee.

A version of this article appeared on Medscape.com.

Patients with obesity but without major depressive disorder or suicidal ideation within the previous 2 years attained meaningful weight loss with semaglutide, regardless of antidepressant use at baseline, in a post hoc analysis of the Semaglutide Treatment Effect in People with Obesity (STEP) program.

Adverse events, including psychiatric events, were slightly more usual in the patients on antidepressants, Robert Kushner, MD, noted, in an oral session at the annual meeting of the Obesity Society.  

“It is very common that patients who present for weight management are taking antidepressants for various reasons, including depression, anxiety, insomnia, or chronic pain,”Dr. Kushner, from Northwestern University in Chicago, said in an email. “We wanted to see if these participants responded differently to semaglutide, compared to those not on antidepressants.”

“We found that antidepressants do not blunt the effect of semaglutide for weight loss,” he said. “However, there is a slight increase in reported adverse effects.”

“Semaglutide 2.4 mg provides an effective treatment option for weight management, regardless of antidepressant use at baseline,” Dr. Kushner summarized. “Clinicians should be assured that we can use semaglutide in this population of patients.”

Jack Yanovski, MD, PhD, said this was a “great presentation,” noting that “it’s really important that we understand what goes on in patients with depression.”

“Of course, all these trials still had rules that prevent the folks with the most severe depressive symptoms or past suicidality to participate,” added Dr. Yanovski, chief of the Growth and Obesity Section, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Md. “We need specific trials to know exactly how well we do.”

Dr. Kushner agreed, but also noted that, ever since some earlier antidepressants were associated with risk for suicidal ideation and death, strict guidelines were put in place that exclude certain patients from participating in clinical trials.

Dr. Yanovski suggested that now that the drugs are approved, it would be possible to study this, and the information would be important for clinicians.

Dr. Kushner said he hopes that such studies are forthcoming. In the meantime, “data like this will add some support and understanding,” he suggested.
 

36,000 Patients with obesity, 500 on antidepressants

Many people living with obesity report taking antidepressants for depression, anxiety, chronic pain, obsessive-compulsive disorder, sleep disturbance, neuropathy, panic disorder, or posttraumatic stress disorder, Dr. Kushner noted.

However, some of these medications can cause weight gain, and little is known about treatment outcomes for people with obesity who are on antidepressants, since most weight-loss studies exclude people with active major depressive disorder.

The researchers analyzed data from 1,961 patients in STEP 1 and 807 patients in STEP 2 as well as 611 patients in STEP 3 and 304 patients in STEP 5 – 3,683 participants in total, of which 539 were on antidepressants at baseline.

The patients were randomly assigned to 2.4 mg semaglutide vs. placebo plus a lifestyle intervention (STEP 1, 2, and 5) or intensive behavioral therapy (STEP 3 only), for 68 weeks, except STEP 5, which was 104 weeks.

Patients were included if they were aged 18 or older with a body mass index ≥30 kg/m², or ≥27 kg/m² with more than one weight-related complication (STEP 1, 3, and 5) or BMI ≥27 kg/m² with type 2 diabetes (STEP 2 only), and at least one self-reported unsuccessful effort to lose weight by diet.

They were excluded if they had active major depressive disorder within 2 years prior to screening (or other severe psychiatric disorders such as schizophrenia or bipolar disorder) or a Patient Health Questionnaire-9 score of 15 or higher (indicating moderately severe or severe depression), or suicide ideation (type 4 or 5 on the Columbia Suicide Severity Rating Scale) or suicide behavior, within 30 days of screening.

From baseline to week 68, patients on semaglutide (with/without baseline antidepressant use) had a significantly greater change in weight vs. patients on placebo (with/without baseline antidepressant use), respectively:

• STEP 1: –15.7% / –14.7% vs. –0.2% / –2.8%
• STEP 2: –10.7% / –9.5% vs. –3.3% / –3.4%
• STEP 3: –16.2% / –15.9% vs. –5.0% / –5.9%
• STEP 5: –19.0% / –14.1% vs. +1.6% / – 4.0%. 

The proportion of reported adverse events was generally slightly greater in patients receiving semaglutide (with/without baseline antidepressant use) than those on placebo (with/without baseline antidepressant use), respectively:

• STEP 1: 97.7% vs 88.6% and 92.9% vs. 86%
• STEP 2: 97.6% vs 86.5% and 88.6% vs. 77.2%
• STEP 3: 97.6% vs 95.3% and 100% vs. 95.8%
• STEP 5: 100% vs 94.8% and 95.5% vs. 89.2%.

Gastrointestinal adverse events were more frequently reported in the semaglutide group and in patients on antidepressants at baseline. The proportion of patients with psychiatric adverse events was greater in participants on antidepressants at baseline. There were no differences in suicidal ideation/behavior in patients with/without antidepressant use at baseline.

The STEP trials were funded by Novo Nordisk. Dr. Kushner discloses that he served as a consultant for Novo Nordisk, WeightWatchers, Eli Lilly, and Pfizer, and received a research grant from Epitomee.

A version of this article appeared on Medscape.com.

Patients with obesity but without major depressive disorder or suicidal ideation within the previous 2 years attained meaningful weight loss with semaglutide, regardless of antidepressant use at baseline, in a post hoc analysis of the Semaglutide Treatment Effect in People with Obesity (STEP) program.

Adverse events, including psychiatric events, were slightly more usual in the patients on antidepressants, Robert Kushner, MD, noted, in an oral session at the annual meeting of the Obesity Society.  

“It is very common that patients who present for weight management are taking antidepressants for various reasons, including depression, anxiety, insomnia, or chronic pain,”Dr. Kushner, from Northwestern University in Chicago, said in an email. “We wanted to see if these participants responded differently to semaglutide, compared to those not on antidepressants.”

“We found that antidepressants do not blunt the effect of semaglutide for weight loss,” he said. “However, there is a slight increase in reported adverse effects.”

“Semaglutide 2.4 mg provides an effective treatment option for weight management, regardless of antidepressant use at baseline,” Dr. Kushner summarized. “Clinicians should be assured that we can use semaglutide in this population of patients.”

Jack Yanovski, MD, PhD, said this was a “great presentation,” noting that “it’s really important that we understand what goes on in patients with depression.”

“Of course, all these trials still had rules that prevent the folks with the most severe depressive symptoms or past suicidality to participate,” added Dr. Yanovski, chief of the Growth and Obesity Section, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, Md. “We need specific trials to know exactly how well we do.”

Dr. Kushner agreed, but also noted that, ever since some earlier antidepressants were associated with risk for suicidal ideation and death, strict guidelines were put in place that exclude certain patients from participating in clinical trials.

Dr. Yanovski suggested that now that the drugs are approved, it would be possible to study this, and the information would be important for clinicians.

Dr. Kushner said he hopes that such studies are forthcoming. In the meantime, “data like this will add some support and understanding,” he suggested.
 

36,000 Patients with obesity, 500 on antidepressants

Many people living with obesity report taking antidepressants for depression, anxiety, chronic pain, obsessive-compulsive disorder, sleep disturbance, neuropathy, panic disorder, or posttraumatic stress disorder, Dr. Kushner noted.

However, some of these medications can cause weight gain, and little is known about treatment outcomes for people with obesity who are on antidepressants, since most weight-loss studies exclude people with active major depressive disorder.

The researchers analyzed data from 1,961 patients in STEP 1 and 807 patients in STEP 2 as well as 611 patients in STEP 3 and 304 patients in STEP 5 – 3,683 participants in total, of which 539 were on antidepressants at baseline.

The patients were randomly assigned to 2.4 mg semaglutide vs. placebo plus a lifestyle intervention (STEP 1, 2, and 5) or intensive behavioral therapy (STEP 3 only), for 68 weeks, except STEP 5, which was 104 weeks.

Patients were included if they were aged 18 or older with a body mass index ≥30 kg/m², or ≥27 kg/m² with more than one weight-related complication (STEP 1, 3, and 5) or BMI ≥27 kg/m² with type 2 diabetes (STEP 2 only), and at least one self-reported unsuccessful effort to lose weight by diet.

They were excluded if they had active major depressive disorder within 2 years prior to screening (or other severe psychiatric disorders such as schizophrenia or bipolar disorder) or a Patient Health Questionnaire-9 score of 15 or higher (indicating moderately severe or severe depression), or suicide ideation (type 4 or 5 on the Columbia Suicide Severity Rating Scale) or suicide behavior, within 30 days of screening.

From baseline to week 68, patients on semaglutide (with/without baseline antidepressant use) had a significantly greater change in weight vs. patients on placebo (with/without baseline antidepressant use), respectively:

• STEP 1: –15.7% / –14.7% vs. –0.2% / –2.8%
• STEP 2: –10.7% / –9.5% vs. –3.3% / –3.4%
• STEP 3: –16.2% / –15.9% vs. –5.0% / –5.9%
• STEP 5: –19.0% / –14.1% vs. +1.6% / – 4.0%. 

The proportion of reported adverse events was generally slightly greater in patients receiving semaglutide (with/without baseline antidepressant use) than those on placebo (with/without baseline antidepressant use), respectively:

• STEP 1: 97.7% vs 88.6% and 92.9% vs. 86%
• STEP 2: 97.6% vs 86.5% and 88.6% vs. 77.2%
• STEP 3: 97.6% vs 95.3% and 100% vs. 95.8%
• STEP 5: 100% vs 94.8% and 95.5% vs. 89.2%.

Gastrointestinal adverse events were more frequently reported in the semaglutide group and in patients on antidepressants at baseline. The proportion of patients with psychiatric adverse events was greater in participants on antidepressants at baseline. There were no differences in suicidal ideation/behavior in patients with/without antidepressant use at baseline.

The STEP trials were funded by Novo Nordisk. Dr. Kushner discloses that he served as a consultant for Novo Nordisk, WeightWatchers, Eli Lilly, and Pfizer, and received a research grant from Epitomee.

A version of this article appeared on Medscape.com.

For women who are obese, daily life is wrought with landmines. Whether it’s the challenges of air travel because plane seats are too small, the need to shield themselves from the world’s discriminating eyes, or the great lengths many will go to achieve better health and the promise of longevity, navigating life as an obese person requires a thick skin.

So, it’s no wonder so many are willing to pay more than $1,000 a month out of pocket to get their hands on drugs like semaglutide (Ozempic and Wegovy) or tirzepatide (Mounjaro). The benefits of these drugs, which are part of a new class called glucagonlike peptide–1 (GLP-1) receptor agonists, include significant and rapid weight loss, blood sugar control, and improved life quality; they are unprecedented in a setting where surgery has long been considered the most effective long-term option.

On the flip side, the desire for rapid weight loss and better blood sugar control also comes with an unexpected cost. Many women living with obesity who take oral contraceptives are unaware that these drugs – especially Mounjaro – can interfere with the absorption of birth control pills and how well they work, making an unintended pregnancy more likely.

Neel Shah, MD, an endocrinologist and associate professor at the University of Texas Health Science Center at Houston, said he has had several patients become pregnant without intending to. 

“It was when Mounjaro came out on the market when we started using it,” he said of the drug the Food and Drug Administration approved for type 2 diabetes in 2022. “It [the warning] was in the product insert, but clinically speaking, I don’t know if it was at the top of providers’ minds when they were prescribing Mounjaro.”

When asked if he believed that we were going to be seeing a significant increase in so-called Mounjaro babies, Dr. Shah was sure in his response. 

“Absolutely. We will because the sheer volume [of patients] will increase,” he said.
 

It’s all in the gut

One of the ways that drugs like Mounjaro work is by delaying the time that it takes for food to move from the stomach to the small intestine. Although data are still evolving, it is believed that this process – delayed gastric emptying – may affect the absorption of birth control pills. 

Dr. Shah said another theory is that vomiting, which is a common side effect of these types of drugs, also affects the pills’ ability to prevent pregnancy. 

And “there’s a prolonged period of ramping up the dose because of the GI side effects,” said Pinar Kodaman, MD, PhD, a reproductive endocrinologist and assistant professor of gynecology at Yale University in New Haven, Conn. 

“Initially, at the lowest dose, there may not be a lot of potential effect on absorption and gastric emptying. But as the dose goes up, it becomes more common, and it can cause diarrhea, which is another condition that can affect the absorption of any medication,” she said.
 

Unanticipated outcomes, extra prevention

Roughly 42% of women in the United States are obese, 40% of whom are between the ages of 20 and 39. Although these new drugs can improve fertility outcomes for women who are obese (especially those with polycystic ovary syndrome, or PCOS), only one – Mounjaro – currently carries a warning about birth control pill effectiveness on its label. Unfortunately, it appears that some doctors are unaware or not counseling patients about this risk, and the data are unclear about whether other drugs in this class, like Ozempic and Wegovy, have the same risks. 

“To date, it hasn’t been a typical thing that we counsel about,” said Dr. Kodaman. “It’s all fairly new, but when we have patients on birth control pills, we do review other medications that they are on because some can affect efficacy, and it’s something to keep in mind.”

It’s also unclear if other forms of birth control – for example, birth control patches that deliver through the skin – might carry similar pregnancy risks. Dr. Shah said some of his patients who became pregnant without intending to were using these patches. This raises even more questions, since they deliver drugs through the skin directly into the bloodstream and not through the GI system. 

What can women do to help ensure that they don’t become pregnant while using these drugs? 

“I really think that if patients want to protect themselves from an unplanned pregnancy, that as soon as they start the GLP receptor agonists, it wouldn’t be a bad idea to use condoms, because the onset of action is pretty quick,” said Dr. Kodaman, noting also that “at the lowest dose there may not be a lot of potential effect on gastric emptying. But as the dose goes up, it becomes much more common or can cause diarrhea.” 

Dr. Shah said that in his practice he’s “been telling patients to add barrier contraception” 4 weeks before they start their first dose “and at any dose adjustment.”

Zoobia Chaudhry, an obesity medicine doctor and assistant professor of medicine at Johns Hopkins University in Baltimore, recommends that “patients just make sure that the injection and medication that they take are at least 1 hour apart.”

“Most of the time, patients do take birth control before bedtime, so if the two are spaced, it should be OK,” she said.

Another option is for women to speak to their doctors about other contraceptive options like IUDs or implantable rods, where gastric absorption is not going to be an issue. 

“There’s very little research on this class of drugs,” said Emily Goodstein, a 40-year-old small-business owner in Washington, who recently switched from Ozempic to Mounjaro. “Being a person who lives in a larger body is such a horrifying experience because of the way that the world discriminates against you.”

She appreciates the feeling of being proactive that these new drugs grant. It has “opened up a bunch of opportunities for me to be seen as a full individual by the medical establishment,” she said. “I was willing to take the risk, knowing that I would be on these drugs for the rest of my life.”

In addition to being what Dr. Goodstein refers to as a guinea pig, she said she made sure that her primary care doctor was aware that she was not trying or planning to become pregnant again. (She has a 3-year-old child.) Still, her doctor mentioned only the most common side effects linked to these drugs, like nausea, vomiting, and diarrhea, and did not mention the risk of pregnancy.

“Folks are really not talking about the reproductive implications,” she said, referring to members of a Facebook group on these drugs that she belongs to. 

Like patients themselves, many doctors are just beginning to get their arms around these agents. “Awareness, education, provider involvement, and having a multidisciplinary team could help patients achieve the goals that they set out for themselves,” said Dr. Shah. 

Clear conversations are key.

A version of this article first appeared on WebMD.com.

For women who are obese, daily life is wrought with landmines. Whether it’s the challenges of air travel because plane seats are too small, the need to shield themselves from the world’s discriminating eyes, or the great lengths many will go to achieve better health and the promise of longevity, navigating life as an obese person requires a thick skin.

So, it’s no wonder so many are willing to pay more than $1,000 a month out of pocket to get their hands on drugs like semaglutide (Ozempic and Wegovy) or tirzepatide (Mounjaro). The benefits of these drugs, which are part of a new class called glucagonlike peptide–1 (GLP-1) receptor agonists, include significant and rapid weight loss, blood sugar control, and improved life quality; they are unprecedented in a setting where surgery has long been considered the most effective long-term option.

On the flip side, the desire for rapid weight loss and better blood sugar control also comes with an unexpected cost. Many women living with obesity who take oral contraceptives are unaware that these drugs – especially Mounjaro – can interfere with the absorption of birth control pills and how well they work, making an unintended pregnancy more likely.

Neel Shah, MD, an endocrinologist and associate professor at the University of Texas Health Science Center at Houston, said he has had several patients become pregnant without intending to. 

“It was when Mounjaro came out on the market when we started using it,” he said of the drug the Food and Drug Administration approved for type 2 diabetes in 2022. “It [the warning] was in the product insert, but clinically speaking, I don’t know if it was at the top of providers’ minds when they were prescribing Mounjaro.”

When asked if he believed that we were going to be seeing a significant increase in so-called Mounjaro babies, Dr. Shah was sure in his response. 

“Absolutely. We will because the sheer volume [of patients] will increase,” he said.
 

It’s all in the gut

One of the ways that drugs like Mounjaro work is by delaying the time that it takes for food to move from the stomach to the small intestine. Although data are still evolving, it is believed that this process – delayed gastric emptying – may affect the absorption of birth control pills. 

Dr. Shah said another theory is that vomiting, which is a common side effect of these types of drugs, also affects the pills’ ability to prevent pregnancy. 

And “there’s a prolonged period of ramping up the dose because of the GI side effects,” said Pinar Kodaman, MD, PhD, a reproductive endocrinologist and assistant professor of gynecology at Yale University in New Haven, Conn. 

“Initially, at the lowest dose, there may not be a lot of potential effect on absorption and gastric emptying. But as the dose goes up, it becomes more common, and it can cause diarrhea, which is another condition that can affect the absorption of any medication,” she said.
 

Unanticipated outcomes, extra prevention

Roughly 42% of women in the United States are obese, 40% of whom are between the ages of 20 and 39. Although these new drugs can improve fertility outcomes for women who are obese (especially those with polycystic ovary syndrome, or PCOS), only one – Mounjaro – currently carries a warning about birth control pill effectiveness on its label. Unfortunately, it appears that some doctors are unaware or not counseling patients about this risk, and the data are unclear about whether other drugs in this class, like Ozempic and Wegovy, have the same risks. 

“To date, it hasn’t been a typical thing that we counsel about,” said Dr. Kodaman. “It’s all fairly new, but when we have patients on birth control pills, we do review other medications that they are on because some can affect efficacy, and it’s something to keep in mind.”

It’s also unclear if other forms of birth control – for example, birth control patches that deliver through the skin – might carry similar pregnancy risks. Dr. Shah said some of his patients who became pregnant without intending to were using these patches. This raises even more questions, since they deliver drugs through the skin directly into the bloodstream and not through the GI system. 

What can women do to help ensure that they don’t become pregnant while using these drugs? 

“I really think that if patients want to protect themselves from an unplanned pregnancy, that as soon as they start the GLP receptor agonists, it wouldn’t be a bad idea to use condoms, because the onset of action is pretty quick,” said Dr. Kodaman, noting also that “at the lowest dose there may not be a lot of potential effect on gastric emptying. But as the dose goes up, it becomes much more common or can cause diarrhea.” 

Dr. Shah said that in his practice he’s “been telling patients to add barrier contraception” 4 weeks before they start their first dose “and at any dose adjustment.”

Zoobia Chaudhry, an obesity medicine doctor and assistant professor of medicine at Johns Hopkins University in Baltimore, recommends that “patients just make sure that the injection and medication that they take are at least 1 hour apart.”

“Most of the time, patients do take birth control before bedtime, so if the two are spaced, it should be OK,” she said.

Another option is for women to speak to their doctors about other contraceptive options like IUDs or implantable rods, where gastric absorption is not going to be an issue. 

“There’s very little research on this class of drugs,” said Emily Goodstein, a 40-year-old small-business owner in Washington, who recently switched from Ozempic to Mounjaro. “Being a person who lives in a larger body is such a horrifying experience because of the way that the world discriminates against you.”

She appreciates the feeling of being proactive that these new drugs grant. It has “opened up a bunch of opportunities for me to be seen as a full individual by the medical establishment,” she said. “I was willing to take the risk, knowing that I would be on these drugs for the rest of my life.”

In addition to being what Dr. Goodstein refers to as a guinea pig, she said she made sure that her primary care doctor was aware that she was not trying or planning to become pregnant again. (She has a 3-year-old child.) Still, her doctor mentioned only the most common side effects linked to these drugs, like nausea, vomiting, and diarrhea, and did not mention the risk of pregnancy.

“Folks are really not talking about the reproductive implications,” she said, referring to members of a Facebook group on these drugs that she belongs to. 

Like patients themselves, many doctors are just beginning to get their arms around these agents. “Awareness, education, provider involvement, and having a multidisciplinary team could help patients achieve the goals that they set out for themselves,” said Dr. Shah. 

Clear conversations are key.

A version of this article first appeared on WebMD.com.

For women who are obese, daily life is wrought with landmines. Whether it’s the challenges of air travel because plane seats are too small, the need to shield themselves from the world’s discriminating eyes, or the great lengths many will go to achieve better health and the promise of longevity, navigating life as an obese person requires a thick skin.

So, it’s no wonder so many are willing to pay more than $1,000 a month out of pocket to get their hands on drugs like semaglutide (Ozempic and Wegovy) or tirzepatide (Mounjaro). The benefits of these drugs, which are part of a new class called glucagonlike peptide–1 (GLP-1) receptor agonists, include significant and rapid weight loss, blood sugar control, and improved life quality; they are unprecedented in a setting where surgery has long been considered the most effective long-term option.

On the flip side, the desire for rapid weight loss and better blood sugar control also comes with an unexpected cost. Many women living with obesity who take oral contraceptives are unaware that these drugs – especially Mounjaro – can interfere with the absorption of birth control pills and how well they work, making an unintended pregnancy more likely.

Neel Shah, MD, an endocrinologist and associate professor at the University of Texas Health Science Center at Houston, said he has had several patients become pregnant without intending to. 

“It was when Mounjaro came out on the market when we started using it,” he said of the drug the Food and Drug Administration approved for type 2 diabetes in 2022. “It [the warning] was in the product insert, but clinically speaking, I don’t know if it was at the top of providers’ minds when they were prescribing Mounjaro.”

When asked if he believed that we were going to be seeing a significant increase in so-called Mounjaro babies, Dr. Shah was sure in his response. 

“Absolutely. We will because the sheer volume [of patients] will increase,” he said.
 

It’s all in the gut

One of the ways that drugs like Mounjaro work is by delaying the time that it takes for food to move from the stomach to the small intestine. Although data are still evolving, it is believed that this process – delayed gastric emptying – may affect the absorption of birth control pills. 

Dr. Shah said another theory is that vomiting, which is a common side effect of these types of drugs, also affects the pills’ ability to prevent pregnancy. 

And “there’s a prolonged period of ramping up the dose because of the GI side effects,” said Pinar Kodaman, MD, PhD, a reproductive endocrinologist and assistant professor of gynecology at Yale University in New Haven, Conn. 

“Initially, at the lowest dose, there may not be a lot of potential effect on absorption and gastric emptying. But as the dose goes up, it becomes more common, and it can cause diarrhea, which is another condition that can affect the absorption of any medication,” she said.
 

Unanticipated outcomes, extra prevention

Roughly 42% of women in the United States are obese, 40% of whom are between the ages of 20 and 39. Although these new drugs can improve fertility outcomes for women who are obese (especially those with polycystic ovary syndrome, or PCOS), only one – Mounjaro – currently carries a warning about birth control pill effectiveness on its label. Unfortunately, it appears that some doctors are unaware or not counseling patients about this risk, and the data are unclear about whether other drugs in this class, like Ozempic and Wegovy, have the same risks. 

“To date, it hasn’t been a typical thing that we counsel about,” said Dr. Kodaman. “It’s all fairly new, but when we have patients on birth control pills, we do review other medications that they are on because some can affect efficacy, and it’s something to keep in mind.”

It’s also unclear if other forms of birth control – for example, birth control patches that deliver through the skin – might carry similar pregnancy risks. Dr. Shah said some of his patients who became pregnant without intending to were using these patches. This raises even more questions, since they deliver drugs through the skin directly into the bloodstream and not through the GI system. 

What can women do to help ensure that they don’t become pregnant while using these drugs? 

“I really think that if patients want to protect themselves from an unplanned pregnancy, that as soon as they start the GLP receptor agonists, it wouldn’t be a bad idea to use condoms, because the onset of action is pretty quick,” said Dr. Kodaman, noting also that “at the lowest dose there may not be a lot of potential effect on gastric emptying. But as the dose goes up, it becomes much more common or can cause diarrhea.” 

Dr. Shah said that in his practice he’s “been telling patients to add barrier contraception” 4 weeks before they start their first dose “and at any dose adjustment.”

Zoobia Chaudhry, an obesity medicine doctor and assistant professor of medicine at Johns Hopkins University in Baltimore, recommends that “patients just make sure that the injection and medication that they take are at least 1 hour apart.”

“Most of the time, patients do take birth control before bedtime, so if the two are spaced, it should be OK,” she said.

Another option is for women to speak to their doctors about other contraceptive options like IUDs or implantable rods, where gastric absorption is not going to be an issue. 

“There’s very little research on this class of drugs,” said Emily Goodstein, a 40-year-old small-business owner in Washington, who recently switched from Ozempic to Mounjaro. “Being a person who lives in a larger body is such a horrifying experience because of the way that the world discriminates against you.”

She appreciates the feeling of being proactive that these new drugs grant. It has “opened up a bunch of opportunities for me to be seen as a full individual by the medical establishment,” she said. “I was willing to take the risk, knowing that I would be on these drugs for the rest of my life.”

In addition to being what Dr. Goodstein refers to as a guinea pig, she said she made sure that her primary care doctor was aware that she was not trying or planning to become pregnant again. (She has a 3-year-old child.) Still, her doctor mentioned only the most common side effects linked to these drugs, like nausea, vomiting, and diarrhea, and did not mention the risk of pregnancy.

“Folks are really not talking about the reproductive implications,” she said, referring to members of a Facebook group on these drugs that she belongs to. 

Like patients themselves, many doctors are just beginning to get their arms around these agents. “Awareness, education, provider involvement, and having a multidisciplinary team could help patients achieve the goals that they set out for themselves,” said Dr. Shah. 

Clear conversations are key.

A version of this article first appeared on WebMD.com.

Obesity is a major factor affecting the health of many Americans. It is estimated by the Centers for Disease Control and Prevention that 41% of adults and 19.7% of children in our country now meet the criteria for being obese. Obesity costs the United States approximately $147 billion annually in health care costs. While these numbers are staggering, they continue to rise.

The recent craze over medications such as Ozempic, Wegovy, and Mounjaro shows how eager people are to lose weight. Yet, many of them face bias, not just in their daily lives, but from health care professionals who should do better. No one should feel stigmatized when they come for medical help. This just drives away patients who need us and who may then suffer more severe consequences of obesity-related illnesses.

Earlier this year, the American Association of Clinical Endocrinology issued a consensus statement on the role stigma and weight bias play in the management of obesity. They proposed a staging system to address the severity of obesity and suggested stigma and bias should be assessed in all patients.

While we are good at diagnosing obesity, many of us fail at addressing it empathetically with patients. I’ve seen many patients cry about past encounters they’ve had in the health care system. We need to address the emotional effect that obesity has as well as the physical complications.

Obesity is a major contributor to many diseases such as diabetes and heart disease, but we are finding it also plays a role in other diseases such as certain cancers. Treating obesity is imperative to prevent these diseases as well as to promote better treatment outcomes. We’ve all seen the diabetic patient lose weight and have their blood glucose levels come under control.

Many patients have tried hard to lose weight yet health care providers talk to them as if they haven’t made any efforts. This is very frustrating for patients. Simply telling a patient to diet and lose weight is a setup for failure. We need to address their past efforts and see what has worked and what hasn’t. Redoing the same thing over and over again is not a recipe for success.

Additionally, the focus on “diet and exercise” fails to account for emotional factors that may be contributing to a person’s obesity. Some people eat when they are stressed or depressed. It can become a habit or even an addiction. If this contributor to obesity isn’t fixed, nothing will work.

However, no medication will work well without the basic building blocks of diet and exercise. Routinely prescribing weight-loss medications without discussing diet and exercise will not result in much weight loss. Some patients simply don’t know how to eat healthfully or what they should do for exercise. A little education can go a long way. Ancillary staff, such as nutritionists or diabetic counselors, can help and free up the doctor’s time. In small practices, we can’t afford to provide those services in house but we should learn where patients can go for these services.

The AACE guidelines do a great job staging obesity. The guidelines make it easier to measure progress and decide on treatment plans. With this system, it is no longer necessary to use terms such as “excess weight” or “morbid obesity.” Patients already know they are overweight. What they need to know are clear steps so that they can reach goals. These guidelines greatly assist with providing those steps.

Most of us can do better when treating patients with obesity, We are probably not even aware of the times we have been guilty of stigmatization or weight bias. When we start treating obesity as a serious medical problem rather than something that’s the fault of the patient, it becomes much easier. When we remind ourselves what can happen to our patients when we fail to treat their obesity, we can become more serious about trying to help them reverse this critical medical problem. Bring an end to throwing out a “lose weight” or “eat healthier” suggestion to our already stressed patients. In order to address the obesity crisis that is here, we need to look inside ourselves and ask how we are going to contribute to the solution.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant of medicine at Robert Wood Johnson Medical School, New Brunswick, N.J.

Obesity is a major factor affecting the health of many Americans. It is estimated by the Centers for Disease Control and Prevention that 41% of adults and 19.7% of children in our country now meet the criteria for being obese. Obesity costs the United States approximately $147 billion annually in health care costs. While these numbers are staggering, they continue to rise.

The recent craze over medications such as Ozempic, Wegovy, and Mounjaro shows how eager people are to lose weight. Yet, many of them face bias, not just in their daily lives, but from health care professionals who should do better. No one should feel stigmatized when they come for medical help. This just drives away patients who need us and who may then suffer more severe consequences of obesity-related illnesses.

Earlier this year, the American Association of Clinical Endocrinology issued a consensus statement on the role stigma and weight bias play in the management of obesity. They proposed a staging system to address the severity of obesity and suggested stigma and bias should be assessed in all patients.

While we are good at diagnosing obesity, many of us fail at addressing it empathetically with patients. I’ve seen many patients cry about past encounters they’ve had in the health care system. We need to address the emotional effect that obesity has as well as the physical complications.

Obesity is a major contributor to many diseases such as diabetes and heart disease, but we are finding it also plays a role in other diseases such as certain cancers. Treating obesity is imperative to prevent these diseases as well as to promote better treatment outcomes. We’ve all seen the diabetic patient lose weight and have their blood glucose levels come under control.

Many patients have tried hard to lose weight yet health care providers talk to them as if they haven’t made any efforts. This is very frustrating for patients. Simply telling a patient to diet and lose weight is a setup for failure. We need to address their past efforts and see what has worked and what hasn’t. Redoing the same thing over and over again is not a recipe for success.

Additionally, the focus on “diet and exercise” fails to account for emotional factors that may be contributing to a person’s obesity. Some people eat when they are stressed or depressed. It can become a habit or even an addiction. If this contributor to obesity isn’t fixed, nothing will work.

However, no medication will work well without the basic building blocks of diet and exercise. Routinely prescribing weight-loss medications without discussing diet and exercise will not result in much weight loss. Some patients simply don’t know how to eat healthfully or what they should do for exercise. A little education can go a long way. Ancillary staff, such as nutritionists or diabetic counselors, can help and free up the doctor’s time. In small practices, we can’t afford to provide those services in house but we should learn where patients can go for these services.

The AACE guidelines do a great job staging obesity. The guidelines make it easier to measure progress and decide on treatment plans. With this system, it is no longer necessary to use terms such as “excess weight” or “morbid obesity.” Patients already know they are overweight. What they need to know are clear steps so that they can reach goals. These guidelines greatly assist with providing those steps.

Most of us can do better when treating patients with obesity, We are probably not even aware of the times we have been guilty of stigmatization or weight bias. When we start treating obesity as a serious medical problem rather than something that’s the fault of the patient, it becomes much easier. When we remind ourselves what can happen to our patients when we fail to treat their obesity, we can become more serious about trying to help them reverse this critical medical problem. Bring an end to throwing out a “lose weight” or “eat healthier” suggestion to our already stressed patients. In order to address the obesity crisis that is here, we need to look inside ourselves and ask how we are going to contribute to the solution.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant of medicine at Robert Wood Johnson Medical School, New Brunswick, N.J.

Obesity is a major factor affecting the health of many Americans. It is estimated by the Centers for Disease Control and Prevention that 41% of adults and 19.7% of children in our country now meet the criteria for being obese. Obesity costs the United States approximately $147 billion annually in health care costs. While these numbers are staggering, they continue to rise.

The recent craze over medications such as Ozempic, Wegovy, and Mounjaro shows how eager people are to lose weight. Yet, many of them face bias, not just in their daily lives, but from health care professionals who should do better. No one should feel stigmatized when they come for medical help. This just drives away patients who need us and who may then suffer more severe consequences of obesity-related illnesses.

Earlier this year, the American Association of Clinical Endocrinology issued a consensus statement on the role stigma and weight bias play in the management of obesity. They proposed a staging system to address the severity of obesity and suggested stigma and bias should be assessed in all patients.

While we are good at diagnosing obesity, many of us fail at addressing it empathetically with patients. I’ve seen many patients cry about past encounters they’ve had in the health care system. We need to address the emotional effect that obesity has as well as the physical complications.

Obesity is a major contributor to many diseases such as diabetes and heart disease, but we are finding it also plays a role in other diseases such as certain cancers. Treating obesity is imperative to prevent these diseases as well as to promote better treatment outcomes. We’ve all seen the diabetic patient lose weight and have their blood glucose levels come under control.

Many patients have tried hard to lose weight yet health care providers talk to them as if they haven’t made any efforts. This is very frustrating for patients. Simply telling a patient to diet and lose weight is a setup for failure. We need to address their past efforts and see what has worked and what hasn’t. Redoing the same thing over and over again is not a recipe for success.

Additionally, the focus on “diet and exercise” fails to account for emotional factors that may be contributing to a person’s obesity. Some people eat when they are stressed or depressed. It can become a habit or even an addiction. If this contributor to obesity isn’t fixed, nothing will work.

However, no medication will work well without the basic building blocks of diet and exercise. Routinely prescribing weight-loss medications without discussing diet and exercise will not result in much weight loss. Some patients simply don’t know how to eat healthfully or what they should do for exercise. A little education can go a long way. Ancillary staff, such as nutritionists or diabetic counselors, can help and free up the doctor’s time. In small practices, we can’t afford to provide those services in house but we should learn where patients can go for these services.

The AACE guidelines do a great job staging obesity. The guidelines make it easier to measure progress and decide on treatment plans. With this system, it is no longer necessary to use terms such as “excess weight” or “morbid obesity.” Patients already know they are overweight. What they need to know are clear steps so that they can reach goals. These guidelines greatly assist with providing those steps.

Most of us can do better when treating patients with obesity, We are probably not even aware of the times we have been guilty of stigmatization or weight bias. When we start treating obesity as a serious medical problem rather than something that’s the fault of the patient, it becomes much easier. When we remind ourselves what can happen to our patients when we fail to treat their obesity, we can become more serious about trying to help them reverse this critical medical problem. Bring an end to throwing out a “lose weight” or “eat healthier” suggestion to our already stressed patients. In order to address the obesity crisis that is here, we need to look inside ourselves and ask how we are going to contribute to the solution.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant of medicine at Robert Wood Johnson Medical School, New Brunswick, N.J.

You can’t argue with success, unless you are an insurance company faced with covering medications shown to improve obesity.

The ability of drugs originally designed for diabetes management to reduce body weight has spiked demand and taxed supplies, according to the U.S. Food and Drug Administration, which included semaglutide (both Wegovy and Ozempic) on its Drug Shortages List as of May 31, 2023.

Meanwhile, clinicians and patients report that insurance companies are pushing back against coverage of these medications that mimic glucagon-like peptide 1 (GLP-1) because of the costs. A recent study conducted by Prime Therapeutics, a pharmacy benefit management organization, showed that individuals who started GLP-1 drugs for weight loss and who were adherent to the treatment averaged a 59% increase in health care costs after 1 year; for those in a subgroup analysis who were treatment adherent, the increase in health care costs was 98%.

“Insurance coverage for obesity treatment is challenging, particularly regarding medications,” said Scott Kahan, MD, director of the National Center for Weight and Wellness at George Washington University, Washington, in an interview. Employers must opt in for patients to have coverage for these medications; therefore, relatively few patients have had access at reasonable out-of-pocket costs, he said.

For example, the University of Texas stated on its website that its prescription drug plans will no longer cover drugs with the active ingredients semaglutide (Wegovy) or liraglutide (Saxenda) for weight loss as of Sept. 1, 2023. Both products are FDA-approved for weight management, whereas the equally popular Ozempic is currently approved only as a treatment for diabetes. The school’s website noted that the current price of the drugs, which cost the plan more than $5 million per month as of May 2023, outstrips the most expensive cancer agents.

The University of Texas also found that among its patients, the compliance rate for those who began Wegovy or Saxenda for weight loss was only 46%, which was not enough to justify continued coverage. The plan advised patients to approach their insurers directly.

Eventually, more information may prompt more support from insurance across a range of medications, Dr. Kahan noted. “Most insurers are wanting cost-effectiveness data in order to support their investments in broader coverage,” he said.

However, costs do vary with and without insurance; some medications are less expensive than others without significant differences in outcomes, so encourage patients to explore all the options and not just one brand, Dr. Kahan said.
 

Educate patients on plan details

Clinicians can’t guarantee coverage, but they can offer guidance to their patients, according to said Andrew Kraftson, MD, an endocrinologist and internal medicine physician at the University of Michigan, Ann Arbor, who specializes in the care of people with obesity.

Unfortunately, some of the challenges to obtaining insurance coverage for weight-loss medications lie in the plan details because some insurers have a blanket prohibition against the use of weight-loss medications, he said.

If patients did not look for this particular aspect of coverage at the time of enrollment in their chosen plan, they may not have known about this exclusion, and they are disappointed to find that they are ineligible for weight-loss medications despite medical circumstances, Dr. Kraftson said in an interview.

If weight-loss medications are covered, prior authorization often is required, Dr. Kraftson added.

“Unfortunately, the requirements vary from insurer to insurer, and this can present challenges for the busy clinicians who may not have dedicated staff to assist with these authorizations. Sometimes, the requirements are exactingly particular, and denials can commonly occur,” he said.

Some insurers will cover weight-loss medications for an initial period then require a certain degree of weight loss before renewing the approval, Dr. Kraftson said.

“While this is reasonable, sometimes it is necessary to titrate a medication more slowly to help a patient get used to the medicine, so they may not reach the required weight loss in the time required by the insurer,” he said. “As such, the medical professional is ‘punished’ for trying to be safe and patient-sensitive, and the patient may lose coverage of the medicine.”

Clinicians can help patients increase their chances for insurance coverage by providing a patient instruction guide to walk them through the steps that allow the patient to make inquiries with their own insurer, Dr. Kraftson said.

This guide should instruct patients on how to read their prescription coverage card to correctly contact their insurer, along with a guide to medical coverage terminology.

Lauren Oshman, MD, also of the University of Michigan, heads a collaborative quality initiative in the state known as Michigan Collaborative for Type 2 Diabetes (MCT2D). Dr. Oshman and her colleagues created a user-friendly list of terms to help patients understand their plans and better advocate for coverage (see below). The list was designed to guide patients with diabetes but applies to any medication.
 

Learn the lingo (common insurance terms and definitions)

• Deductible: Predetermined amount that must be paid annually before insurance pays for anything.
• Copayment: Set amount paid for a prescription.
• Coinsurance: Amount you pay after your deductible is met. Your insurance pays their portion. Coinsurance only applies to prescriptions and services covered under your health plan.
• Medication tier: Levels of insurance medication coverage; you play a smaller amount for a lower tier and a higher amount for a higher tier.
• Out-of-pocket max: Annual limit on what you pay before insurance covers 100% of covered services. Deductibles, copayment, and coinsurance all apply toward your out-of-pocket maximum.
• Prior authorization: Request made by your doctor to insurance company for coverage of a medication.
• Quantity limit: Limitation on the number of pills covered for a period of time.
• Step therapy: Medication you must have tried prior to approval of a nonpreferred medication, typically prior to trying a more expensive medication.

(Source: Learn the Lingo: A Guide to Common Insurance Terms and Definitions, courtesy of Lauren Oshman, MD, and MCT2D)

Also, make sure patients understand that they need to find out whether they have a deductible and if so, how much it is, Dr. Kraftson said.

Pros and cons of compounding

Compounded drugs are not approved by the FDA; however, that does not mean they are not available, and patients may pursue them as an option for weight-loss drugs.

In a statement issued on May 31, 2023, the FDA cited reports of adverse events associated with the use of compounded weight-loss drugs as a lower-cost alternative to the approved product. The FDA emphasized that the agency does not review compounded versions of weight-loss drugs for safety, efficacy, or quality.

Dr. Kraftson cited the lack of quality control, transparency, and safety data as reasons to discourage his patients from pursuing compounded medications.

“If a patient insists on pursuing it, then I review the position statement from the Obesity Medicine Association,” he said. The OMA statement recommends that anti-obesity medications undergo clinical trials and noted the lack of FDA oversight on these products. The OMA statement also advises compounded peptides to be “legally produced by companies whose identities are readily disclosed, and who have documented manufacturing processes compliant with oversight by applicable regulatory agencies.”
 

Tracking outcomes might boost coverage

Robust data on the long-term cost-effectiveness of weight-loss medications are lacking, although this is changing, Dr. Kraftson said. A 2022 study published last year in the Journal of Managed Care and Specialty Pharmacy showed that a 2.4-mg dose of semaglutide was cost-effective, compared with no treatment, diet and exercise, and other anti-obesity medications based on gains in quality of life.

“Regardless, insurers are not as motivated by long-term cost effectiveness,” Dr. Kraftson said. Insurers are accustomed to employee turnover and are more likely to be motivated by short-term costs and benefits, he said. “Obesity treatment provides some short-term benefit, but the majority of the benefit can be experienced when we look at the long-term horizon,” he said.

Looking ahead, “We need better ways to account for the myriad benefits experienced by patients with successful weight control beyond what is currently measured as metrics of success, including better ways to qualify and quantify quality-of-life benefits,” Dr. Kraftson said.

Also, clinicians should address the stigma associated with obesity, Dr. Kraftson said.

“We would not see the spate of coverage restrictions if we were talking about heart disease or cancer; insurers can get away with this because obesity is held to a different standard and patients with obesity are used to being undertreated and mistreated by the medical community and society,” he said. “We need to better account for the true costs of excess weight/obesity beyond what is traditionally accepted. This would help make the case for the cost-effective nature of treatment.”

Dr. Kraftson and Dr. Oshman disclosed no relevant financial relationships. Dr. Kahan had no financial conflicts and serves on the Medscape Editorial Advisory Board.

You can’t argue with success, unless you are an insurance company faced with covering medications shown to improve obesity.

The ability of drugs originally designed for diabetes management to reduce body weight has spiked demand and taxed supplies, according to the U.S. Food and Drug Administration, which included semaglutide (both Wegovy and Ozempic) on its Drug Shortages List as of May 31, 2023.

Meanwhile, clinicians and patients report that insurance companies are pushing back against coverage of these medications that mimic glucagon-like peptide 1 (GLP-1) because of the costs. A recent study conducted by Prime Therapeutics, a pharmacy benefit management organization, showed that individuals who started GLP-1 drugs for weight loss and who were adherent to the treatment averaged a 59% increase in health care costs after 1 year; for those in a subgroup analysis who were treatment adherent, the increase in health care costs was 98%.

“Insurance coverage for obesity treatment is challenging, particularly regarding medications,” said Scott Kahan, MD, director of the National Center for Weight and Wellness at George Washington University, Washington, in an interview. Employers must opt in for patients to have coverage for these medications; therefore, relatively few patients have had access at reasonable out-of-pocket costs, he said.

For example, the University of Texas stated on its website that its prescription drug plans will no longer cover drugs with the active ingredients semaglutide (Wegovy) or liraglutide (Saxenda) for weight loss as of Sept. 1, 2023. Both products are FDA-approved for weight management, whereas the equally popular Ozempic is currently approved only as a treatment for diabetes. The school’s website noted that the current price of the drugs, which cost the plan more than $5 million per month as of May 2023, outstrips the most expensive cancer agents.

The University of Texas also found that among its patients, the compliance rate for those who began Wegovy or Saxenda for weight loss was only 46%, which was not enough to justify continued coverage. The plan advised patients to approach their insurers directly.

Eventually, more information may prompt more support from insurance across a range of medications, Dr. Kahan noted. “Most insurers are wanting cost-effectiveness data in order to support their investments in broader coverage,” he said.

However, costs do vary with and without insurance; some medications are less expensive than others without significant differences in outcomes, so encourage patients to explore all the options and not just one brand, Dr. Kahan said.
 

Educate patients on plan details

Clinicians can’t guarantee coverage, but they can offer guidance to their patients, according to said Andrew Kraftson, MD, an endocrinologist and internal medicine physician at the University of Michigan, Ann Arbor, who specializes in the care of people with obesity.

Unfortunately, some of the challenges to obtaining insurance coverage for weight-loss medications lie in the plan details because some insurers have a blanket prohibition against the use of weight-loss medications, he said.

If patients did not look for this particular aspect of coverage at the time of enrollment in their chosen plan, they may not have known about this exclusion, and they are disappointed to find that they are ineligible for weight-loss medications despite medical circumstances, Dr. Kraftson said in an interview.

If weight-loss medications are covered, prior authorization often is required, Dr. Kraftson added.

“Unfortunately, the requirements vary from insurer to insurer, and this can present challenges for the busy clinicians who may not have dedicated staff to assist with these authorizations. Sometimes, the requirements are exactingly particular, and denials can commonly occur,” he said.

Some insurers will cover weight-loss medications for an initial period then require a certain degree of weight loss before renewing the approval, Dr. Kraftson said.

“While this is reasonable, sometimes it is necessary to titrate a medication more slowly to help a patient get used to the medicine, so they may not reach the required weight loss in the time required by the insurer,” he said. “As such, the medical professional is ‘punished’ for trying to be safe and patient-sensitive, and the patient may lose coverage of the medicine.”

Clinicians can help patients increase their chances for insurance coverage by providing a patient instruction guide to walk them through the steps that allow the patient to make inquiries with their own insurer, Dr. Kraftson said.

This guide should instruct patients on how to read their prescription coverage card to correctly contact their insurer, along with a guide to medical coverage terminology.

Lauren Oshman, MD, also of the University of Michigan, heads a collaborative quality initiative in the state known as Michigan Collaborative for Type 2 Diabetes (MCT2D). Dr. Oshman and her colleagues created a user-friendly list of terms to help patients understand their plans and better advocate for coverage (see below). The list was designed to guide patients with diabetes but applies to any medication.
 

Learn the lingo (common insurance terms and definitions)

• Deductible: Predetermined amount that must be paid annually before insurance pays for anything.
• Copayment: Set amount paid for a prescription.
• Coinsurance: Amount you pay after your deductible is met. Your insurance pays their portion. Coinsurance only applies to prescriptions and services covered under your health plan.
• Medication tier: Levels of insurance medication coverage; you play a smaller amount for a lower tier and a higher amount for a higher tier.
• Out-of-pocket max: Annual limit on what you pay before insurance covers 100% of covered services. Deductibles, copayment, and coinsurance all apply toward your out-of-pocket maximum.
• Prior authorization: Request made by your doctor to insurance company for coverage of a medication.
• Quantity limit: Limitation on the number of pills covered for a period of time.
• Step therapy: Medication you must have tried prior to approval of a nonpreferred medication, typically prior to trying a more expensive medication.

(Source: Learn the Lingo: A Guide to Common Insurance Terms and Definitions, courtesy of Lauren Oshman, MD, and MCT2D)

Also, make sure patients understand that they need to find out whether they have a deductible and if so, how much it is, Dr. Kraftson said.

Pros and cons of compounding

Compounded drugs are not approved by the FDA; however, that does not mean they are not available, and patients may pursue them as an option for weight-loss drugs.

In a statement issued on May 31, 2023, the FDA cited reports of adverse events associated with the use of compounded weight-loss drugs as a lower-cost alternative to the approved product. The FDA emphasized that the agency does not review compounded versions of weight-loss drugs for safety, efficacy, or quality.

Dr. Kraftson cited the lack of quality control, transparency, and safety data as reasons to discourage his patients from pursuing compounded medications.

“If a patient insists on pursuing it, then I review the position statement from the Obesity Medicine Association,” he said. The OMA statement recommends that anti-obesity medications undergo clinical trials and noted the lack of FDA oversight on these products. The OMA statement also advises compounded peptides to be “legally produced by companies whose identities are readily disclosed, and who have documented manufacturing processes compliant with oversight by applicable regulatory agencies.”
 

Tracking outcomes might boost coverage

Robust data on the long-term cost-effectiveness of weight-loss medications are lacking, although this is changing, Dr. Kraftson said. A 2022 study published last year in the Journal of Managed Care and Specialty Pharmacy showed that a 2.4-mg dose of semaglutide was cost-effective, compared with no treatment, diet and exercise, and other anti-obesity medications based on gains in quality of life.

“Regardless, insurers are not as motivated by long-term cost effectiveness,” Dr. Kraftson said. Insurers are accustomed to employee turnover and are more likely to be motivated by short-term costs and benefits, he said. “Obesity treatment provides some short-term benefit, but the majority of the benefit can be experienced when we look at the long-term horizon,” he said.

Looking ahead, “We need better ways to account for the myriad benefits experienced by patients with successful weight control beyond what is currently measured as metrics of success, including better ways to qualify and quantify quality-of-life benefits,” Dr. Kraftson said.

Also, clinicians should address the stigma associated with obesity, Dr. Kraftson said.

“We would not see the spate of coverage restrictions if we were talking about heart disease or cancer; insurers can get away with this because obesity is held to a different standard and patients with obesity are used to being undertreated and mistreated by the medical community and society,” he said. “We need to better account for the true costs of excess weight/obesity beyond what is traditionally accepted. This would help make the case for the cost-effective nature of treatment.”

Dr. Kraftson and Dr. Oshman disclosed no relevant financial relationships. Dr. Kahan had no financial conflicts and serves on the Medscape Editorial Advisory Board.

You can’t argue with success, unless you are an insurance company faced with covering medications shown to improve obesity.

The ability of drugs originally designed for diabetes management to reduce body weight has spiked demand and taxed supplies, according to the U.S. Food and Drug Administration, which included semaglutide (both Wegovy and Ozempic) on its Drug Shortages List as of May 31, 2023.

Meanwhile, clinicians and patients report that insurance companies are pushing back against coverage of these medications that mimic glucagon-like peptide 1 (GLP-1) because of the costs. A recent study conducted by Prime Therapeutics, a pharmacy benefit management organization, showed that individuals who started GLP-1 drugs for weight loss and who were adherent to the treatment averaged a 59% increase in health care costs after 1 year; for those in a subgroup analysis who were treatment adherent, the increase in health care costs was 98%.

“Insurance coverage for obesity treatment is challenging, particularly regarding medications,” said Scott Kahan, MD, director of the National Center for Weight and Wellness at George Washington University, Washington, in an interview. Employers must opt in for patients to have coverage for these medications; therefore, relatively few patients have had access at reasonable out-of-pocket costs, he said.

For example, the University of Texas stated on its website that its prescription drug plans will no longer cover drugs with the active ingredients semaglutide (Wegovy) or liraglutide (Saxenda) for weight loss as of Sept. 1, 2023. Both products are FDA-approved for weight management, whereas the equally popular Ozempic is currently approved only as a treatment for diabetes. The school’s website noted that the current price of the drugs, which cost the plan more than $5 million per month as of May 2023, outstrips the most expensive cancer agents.

The University of Texas also found that among its patients, the compliance rate for those who began Wegovy or Saxenda for weight loss was only 46%, which was not enough to justify continued coverage. The plan advised patients to approach their insurers directly.

Eventually, more information may prompt more support from insurance across a range of medications, Dr. Kahan noted. “Most insurers are wanting cost-effectiveness data in order to support their investments in broader coverage,” he said.

However, costs do vary with and without insurance; some medications are less expensive than others without significant differences in outcomes, so encourage patients to explore all the options and not just one brand, Dr. Kahan said.
 

Educate patients on plan details

Clinicians can’t guarantee coverage, but they can offer guidance to their patients, according to said Andrew Kraftson, MD, an endocrinologist and internal medicine physician at the University of Michigan, Ann Arbor, who specializes in the care of people with obesity.

Unfortunately, some of the challenges to obtaining insurance coverage for weight-loss medications lie in the plan details because some insurers have a blanket prohibition against the use of weight-loss medications, he said.

If patients did not look for this particular aspect of coverage at the time of enrollment in their chosen plan, they may not have known about this exclusion, and they are disappointed to find that they are ineligible for weight-loss medications despite medical circumstances, Dr. Kraftson said in an interview.

If weight-loss medications are covered, prior authorization often is required, Dr. Kraftson added.

“Unfortunately, the requirements vary from insurer to insurer, and this can present challenges for the busy clinicians who may not have dedicated staff to assist with these authorizations. Sometimes, the requirements are exactingly particular, and denials can commonly occur,” he said.

Some insurers will cover weight-loss medications for an initial period then require a certain degree of weight loss before renewing the approval, Dr. Kraftson said.

“While this is reasonable, sometimes it is necessary to titrate a medication more slowly to help a patient get used to the medicine, so they may not reach the required weight loss in the time required by the insurer,” he said. “As such, the medical professional is ‘punished’ for trying to be safe and patient-sensitive, and the patient may lose coverage of the medicine.”

Clinicians can help patients increase their chances for insurance coverage by providing a patient instruction guide to walk them through the steps that allow the patient to make inquiries with their own insurer, Dr. Kraftson said.

This guide should instruct patients on how to read their prescription coverage card to correctly contact their insurer, along with a guide to medical coverage terminology.

Lauren Oshman, MD, also of the University of Michigan, heads a collaborative quality initiative in the state known as Michigan Collaborative for Type 2 Diabetes (MCT2D). Dr. Oshman and her colleagues created a user-friendly list of terms to help patients understand their plans and better advocate for coverage (see below). The list was designed to guide patients with diabetes but applies to any medication.
 

Learn the lingo (common insurance terms and definitions)

• Deductible: Predetermined amount that must be paid annually before insurance pays for anything.
• Copayment: Set amount paid for a prescription.
• Coinsurance: Amount you pay after your deductible is met. Your insurance pays their portion. Coinsurance only applies to prescriptions and services covered under your health plan.
• Medication tier: Levels of insurance medication coverage; you play a smaller amount for a lower tier and a higher amount for a higher tier.
• Out-of-pocket max: Annual limit on what you pay before insurance covers 100% of covered services. Deductibles, copayment, and coinsurance all apply toward your out-of-pocket maximum.
• Prior authorization: Request made by your doctor to insurance company for coverage of a medication.
• Quantity limit: Limitation on the number of pills covered for a period of time.
• Step therapy: Medication you must have tried prior to approval of a nonpreferred medication, typically prior to trying a more expensive medication.

(Source: Learn the Lingo: A Guide to Common Insurance Terms and Definitions, courtesy of Lauren Oshman, MD, and MCT2D)

Also, make sure patients understand that they need to find out whether they have a deductible and if so, how much it is, Dr. Kraftson said.

Pros and cons of compounding

Compounded drugs are not approved by the FDA; however, that does not mean they are not available, and patients may pursue them as an option for weight-loss drugs.

In a statement issued on May 31, 2023, the FDA cited reports of adverse events associated with the use of compounded weight-loss drugs as a lower-cost alternative to the approved product. The FDA emphasized that the agency does not review compounded versions of weight-loss drugs for safety, efficacy, or quality.

Dr. Kraftson cited the lack of quality control, transparency, and safety data as reasons to discourage his patients from pursuing compounded medications.

“If a patient insists on pursuing it, then I review the position statement from the Obesity Medicine Association,” he said. The OMA statement recommends that anti-obesity medications undergo clinical trials and noted the lack of FDA oversight on these products. The OMA statement also advises compounded peptides to be “legally produced by companies whose identities are readily disclosed, and who have documented manufacturing processes compliant with oversight by applicable regulatory agencies.”
 

Tracking outcomes might boost coverage

Robust data on the long-term cost-effectiveness of weight-loss medications are lacking, although this is changing, Dr. Kraftson said. A 2022 study published last year in the Journal of Managed Care and Specialty Pharmacy showed that a 2.4-mg dose of semaglutide was cost-effective, compared with no treatment, diet and exercise, and other anti-obesity medications based on gains in quality of life.

“Regardless, insurers are not as motivated by long-term cost effectiveness,” Dr. Kraftson said. Insurers are accustomed to employee turnover and are more likely to be motivated by short-term costs and benefits, he said. “Obesity treatment provides some short-term benefit, but the majority of the benefit can be experienced when we look at the long-term horizon,” he said.

Looking ahead, “We need better ways to account for the myriad benefits experienced by patients with successful weight control beyond what is currently measured as metrics of success, including better ways to qualify and quantify quality-of-life benefits,” Dr. Kraftson said.

Also, clinicians should address the stigma associated with obesity, Dr. Kraftson said.

“We would not see the spate of coverage restrictions if we were talking about heart disease or cancer; insurers can get away with this because obesity is held to a different standard and patients with obesity are used to being undertreated and mistreated by the medical community and society,” he said. “We need to better account for the true costs of excess weight/obesity beyond what is traditionally accepted. This would help make the case for the cost-effective nature of treatment.”

Dr. Kraftson and Dr. Oshman disclosed no relevant financial relationships. Dr. Kahan had no financial conflicts and serves on the Medscape Editorial Advisory Board.

A process your body uses to stay warm in cool weather could one day lead to new therapies for obesity.

Scientists have, for the first time, mapped the precise nerve pathways that activate brown fat, or brown adipose tissue (BAT), a specialized fat that generates heat. Low temperatures kick brown fat into gear, helping the body keep its temperature and burning calories in the process.

“It has long been speculated that activating this type of fat may be useful in treating obesity and related metabolic conditions,” said Preethi Srikanthan, MD, an endocrinologist and professor of medicine who oversaw the research at the UCLA School of Medicine. “The challenge has been finding a way of selectively stimulating [it].”

Brown fat is different from the fat typically linked to obesity: the kind that accumulates around the belly, hips, and thighs. That’s white fat. White fat stores energy; brown fat burns it. That’s because brown fat cells have more mitochondria, a part of the cell that generates energy. 

After dissecting the necks of eight human cadavers, Dr. Srikanthan and her team traced the sympathetic nerve branches in the fat pad above the collarbone – where the largest depot of brown fat in adults is stored. They stained the nerves, took samples, and viewed them under a microscope. 

They found that nerves from brown fat traveled to the third and fourth cranial nerves of the brain, bundles of nerve fibers that control blinking and some eye movements.

In a previous case study, damage to these nerves appeared to block a chemical tracer from reaching brown fat. The evidence suggests that changing this nerve supply could alter brown fat activity, potentially leading to new treatments for obesity and metabolic diseases like type 2 diabetes, Dr. Srikanthan said.
 

A possible mechanism for Ozempic?

Brown fat has already been linked to at least one breakthrough in obesity treatment. Some evidence suggests that popular medications like semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro) may affect brown fat activity. These belong to a class of drugs known as glucagon-like peptide-1 (GLP-1) receptor agonists. They work by mimicking the hormone GLP-1, which is released in the gut and brain in response to eating glucose (sugary foods or drinks).

“GLP-1 agonists have been shown to increase [brown fat] activity in rodents and humans, but likely indirectly, via activation of specific regions in the brain,” explained Varman Samuel, MD, PhD, an associate professor of medicine at the Yale School of Medicine, New Haven, Conn., and chief of endocrinology for the VA Connecticut Healthcare System. 

The scientific literature is divided on this, but there is enough evidence to support further inquiry, Dr. Srikanthan said. Her team has begun a study to examine that link.
 

Opening the door to future obesity treatments

But their discovery means other new treatments could be on the horizon. 

Previous research had shown that the sympathetic nervous system drives brown fat activity. But now that the UCLA scientists have revealed the exact nerves connecting brown fat to the sympathetic nervous system, we could find ways to stimulate those pathways to activate brown fat – without stimulating the many organs (such as the heart and stomach) also connected to this vast network of nerves, Dr. Srikanthan said. 

Methods for doing that could include medication, electrical stimulation, or heat therapy, according to the study. 

Still, there is reason to temper expectations. “[Brown fat] depots, while highly metabolically active, are quite small,” Dr. Samuel said. “So, the overall contribution to whole-body energy balance in humans will likely be small.”

On the other hand, that prediction doesn’t account for what we don’t know. 

“We’re learning more about how tissues communicate with each other, beyond the release of hormones or metabolites,” Dr. Samuel said. Activating brown fat could trigger “signals that help coordinate whole-body energy metabolism.”

A version of this article first appeared on WebMD.com.

A process your body uses to stay warm in cool weather could one day lead to new therapies for obesity.

Scientists have, for the first time, mapped the precise nerve pathways that activate brown fat, or brown adipose tissue (BAT), a specialized fat that generates heat. Low temperatures kick brown fat into gear, helping the body keep its temperature and burning calories in the process.

“It has long been speculated that activating this type of fat may be useful in treating obesity and related metabolic conditions,” said Preethi Srikanthan, MD, an endocrinologist and professor of medicine who oversaw the research at the UCLA School of Medicine. “The challenge has been finding a way of selectively stimulating [it].”

Brown fat is different from the fat typically linked to obesity: the kind that accumulates around the belly, hips, and thighs. That’s white fat. White fat stores energy; brown fat burns it. That’s because brown fat cells have more mitochondria, a part of the cell that generates energy. 

After dissecting the necks of eight human cadavers, Dr. Srikanthan and her team traced the sympathetic nerve branches in the fat pad above the collarbone – where the largest depot of brown fat in adults is stored. They stained the nerves, took samples, and viewed them under a microscope. 

They found that nerves from brown fat traveled to the third and fourth cranial nerves of the brain, bundles of nerve fibers that control blinking and some eye movements.

In a previous case study, damage to these nerves appeared to block a chemical tracer from reaching brown fat. The evidence suggests that changing this nerve supply could alter brown fat activity, potentially leading to new treatments for obesity and metabolic diseases like type 2 diabetes, Dr. Srikanthan said.
 

A possible mechanism for Ozempic?

Brown fat has already been linked to at least one breakthrough in obesity treatment. Some evidence suggests that popular medications like semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro) may affect brown fat activity. These belong to a class of drugs known as glucagon-like peptide-1 (GLP-1) receptor agonists. They work by mimicking the hormone GLP-1, which is released in the gut and brain in response to eating glucose (sugary foods or drinks).

“GLP-1 agonists have been shown to increase [brown fat] activity in rodents and humans, but likely indirectly, via activation of specific regions in the brain,” explained Varman Samuel, MD, PhD, an associate professor of medicine at the Yale School of Medicine, New Haven, Conn., and chief of endocrinology for the VA Connecticut Healthcare System. 

The scientific literature is divided on this, but there is enough evidence to support further inquiry, Dr. Srikanthan said. Her team has begun a study to examine that link.
 

Opening the door to future obesity treatments

But their discovery means other new treatments could be on the horizon. 

Previous research had shown that the sympathetic nervous system drives brown fat activity. But now that the UCLA scientists have revealed the exact nerves connecting brown fat to the sympathetic nervous system, we could find ways to stimulate those pathways to activate brown fat – without stimulating the many organs (such as the heart and stomach) also connected to this vast network of nerves, Dr. Srikanthan said. 

Methods for doing that could include medication, electrical stimulation, or heat therapy, according to the study. 

Still, there is reason to temper expectations. “[Brown fat] depots, while highly metabolically active, are quite small,” Dr. Samuel said. “So, the overall contribution to whole-body energy balance in humans will likely be small.”

On the other hand, that prediction doesn’t account for what we don’t know. 

“We’re learning more about how tissues communicate with each other, beyond the release of hormones or metabolites,” Dr. Samuel said. Activating brown fat could trigger “signals that help coordinate whole-body energy metabolism.”

A version of this article first appeared on WebMD.com.

A process your body uses to stay warm in cool weather could one day lead to new therapies for obesity.

Scientists have, for the first time, mapped the precise nerve pathways that activate brown fat, or brown adipose tissue (BAT), a specialized fat that generates heat. Low temperatures kick brown fat into gear, helping the body keep its temperature and burning calories in the process.

“It has long been speculated that activating this type of fat may be useful in treating obesity and related metabolic conditions,” said Preethi Srikanthan, MD, an endocrinologist and professor of medicine who oversaw the research at the UCLA School of Medicine. “The challenge has been finding a way of selectively stimulating [it].”

Brown fat is different from the fat typically linked to obesity: the kind that accumulates around the belly, hips, and thighs. That’s white fat. White fat stores energy; brown fat burns it. That’s because brown fat cells have more mitochondria, a part of the cell that generates energy. 

After dissecting the necks of eight human cadavers, Dr. Srikanthan and her team traced the sympathetic nerve branches in the fat pad above the collarbone – where the largest depot of brown fat in adults is stored. They stained the nerves, took samples, and viewed them under a microscope. 

They found that nerves from brown fat traveled to the third and fourth cranial nerves of the brain, bundles of nerve fibers that control blinking and some eye movements.

In a previous case study, damage to these nerves appeared to block a chemical tracer from reaching brown fat. The evidence suggests that changing this nerve supply could alter brown fat activity, potentially leading to new treatments for obesity and metabolic diseases like type 2 diabetes, Dr. Srikanthan said.
 

A possible mechanism for Ozempic?

Brown fat has already been linked to at least one breakthrough in obesity treatment. Some evidence suggests that popular medications like semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro) may affect brown fat activity. These belong to a class of drugs known as glucagon-like peptide-1 (GLP-1) receptor agonists. They work by mimicking the hormone GLP-1, which is released in the gut and brain in response to eating glucose (sugary foods or drinks).

“GLP-1 agonists have been shown to increase [brown fat] activity in rodents and humans, but likely indirectly, via activation of specific regions in the brain,” explained Varman Samuel, MD, PhD, an associate professor of medicine at the Yale School of Medicine, New Haven, Conn., and chief of endocrinology for the VA Connecticut Healthcare System. 

The scientific literature is divided on this, but there is enough evidence to support further inquiry, Dr. Srikanthan said. Her team has begun a study to examine that link.
 

Opening the door to future obesity treatments

But their discovery means other new treatments could be on the horizon. 

Previous research had shown that the sympathetic nervous system drives brown fat activity. But now that the UCLA scientists have revealed the exact nerves connecting brown fat to the sympathetic nervous system, we could find ways to stimulate those pathways to activate brown fat – without stimulating the many organs (such as the heart and stomach) also connected to this vast network of nerves, Dr. Srikanthan said. 

Methods for doing that could include medication, electrical stimulation, or heat therapy, according to the study. 

Still, there is reason to temper expectations. “[Brown fat] depots, while highly metabolically active, are quite small,” Dr. Samuel said. “So, the overall contribution to whole-body energy balance in humans will likely be small.”

On the other hand, that prediction doesn’t account for what we don’t know. 

“We’re learning more about how tissues communicate with each other, beyond the release of hormones or metabolites,” Dr. Samuel said. Activating brown fat could trigger “signals that help coordinate whole-body energy metabolism.”

A version of this article first appeared on WebMD.com.