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Can an endoscopic procedure treat type 2 diabetes?
Called recellularization via electroporation therapy (ReCET), the technology, manufactured by Endogenex, uses a specialized catheter to deliver alternating electric pulses to the duodenum to induce cellular regeneration. This process is thought to improve insulin sensitivity, in part, by altering gut hormones and nutritional sensing, principal investigator Jacques Bergman, MD, PhD, said in a press briefing held in conjunction with the annual Digestive Disease Week® (DDW), where he will present the data on May 9.
In the first-in-human study of ReCET, 12 of 14 patients were able to come off insulin for up to a year following the procedure when combined with the use of the glucagonlike peptide–1 agonist semaglutide.
“This might be a game changer in the management of type 2 diabetes because a single outpatient endoscopic intervention was suggested to have a pretty long therapeutic effect, which is compliance-free, as opposed to drug therapy that relies on patients taking the drugs on a daily basis,” said Dr. Bergman, professor of gastrointestinal endoscopy at Amsterdam University Medical Center.
Moreover, he added, “this technique is disease-modifying, so it goes to the root cause of type 2 diabetes and tackles the insulin resistance, as opposed to drug therapy, which at best, is disease-controlling, and the effect is immediately gone if you stop the medication.”
ReCET is similar to another product, Fractyl’s Revita DMR, for which Dr. Bergman was involved in a randomized clinical trial. He said in an interview that the two technologies differ in that the Revita uses heat with submucosal lifting to avoid deeper heat penetration, whereas ReCET is nonthermal. He is also involved in a second randomized trial of the Revita.
Is semaglutide muddying the findings?
Asked to comment about the current study with ReCET, Ali Aminian, MD, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic, said that the treatment effect is certainly plausible.
“The observation that hyperglycemia rapidly and substantially improves after bariatric surgery has prompted innovators to search for novel endoscopic procedures targeting the GI tract to improve diabetes and metabolic disease. Over the years, we learned that in addition to its role in digestion and absorption, the GI tract is actually a large endocrine organ which contributes to development of diabetes and metabolic disease.”
However, Dr. Aminian said that, “while these preliminary findings on a very small number of patients with a very short follow-up time are interesting,” he faulted the study design for including semaglutide. “When patients are treated with a combination of therapies, it will be hard to understand the true effect of each therapy,” and particularly, “when we add a strong diabetes medication like semaglutide.”
Dr. Bergman said semaglutide was used to “boost the insulin-resistant effect of the endoscopic treatment,” and that a planned double-blind, randomized trial will “show how much semaglutide actually contributed to the effect.” The ultimate goal, he noted, is to eliminate the need for all medications.
Moreover, when people with type 2 diabetes add semaglutide to insulin treatment, only about 20% typically are able to quit taking the insulin, in contrast to the 86% seen in this study, lead author Celine Busch, MBBS, a PhD candidate in gastroenterology at Amsterdam University, said in a DDW statement.
Dr. Aminian said, “I’m looking forward to better quality data ... from studies with a stronger design to prove safety, efficacy, and durability of this endoscopic intervention in patients with diabetes.”
But, he also cautioned, “in the past few years, other endoscopic procedures targeting the duodenum were introduced with exciting initial findings based on a small series [with a] short-term follow-up time. However, their safety, efficacy, and durability were not proven in subsequent studies.”
All patients stopped insulin, most for a year
The single-arm, single-center study involved 14 patients with type 2 diabetes taking basal but not premeal insulin. All underwent the 1-hour outpatient ReCET procedure, which involved placing a catheter into the first part of the small bowel and delivering electrical pulses to the duodenum.
Patients adhered to a calorie-controlled liquid diet for 2 weeks, after which they were initiated on semaglutide. All 14 patients were able to come off insulin for 3 months while maintaining glycemic control, and 12 were able to come off insulin for 12 months. They also experienced a 50% reduction in liver fat.
Dr. Bergman said a randomized, double-blind study using a sham procedure for controls is expected to start in about 2 months. “But for now, we are very encouraged by the potential for controlling type 2 diabetes with a single endoscopic treatment.”
Dr. Bergman has reported serving on the advisory board for Endogenex. Dr. Aminian has reported receiving research support and honorarium from Medtronic and Ethicon.
The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.
A version of this article first appeared on Medscape.com.
Called recellularization via electroporation therapy (ReCET), the technology, manufactured by Endogenex, uses a specialized catheter to deliver alternating electric pulses to the duodenum to induce cellular regeneration. This process is thought to improve insulin sensitivity, in part, by altering gut hormones and nutritional sensing, principal investigator Jacques Bergman, MD, PhD, said in a press briefing held in conjunction with the annual Digestive Disease Week® (DDW), where he will present the data on May 9.
In the first-in-human study of ReCET, 12 of 14 patients were able to come off insulin for up to a year following the procedure when combined with the use of the glucagonlike peptide–1 agonist semaglutide.
“This might be a game changer in the management of type 2 diabetes because a single outpatient endoscopic intervention was suggested to have a pretty long therapeutic effect, which is compliance-free, as opposed to drug therapy that relies on patients taking the drugs on a daily basis,” said Dr. Bergman, professor of gastrointestinal endoscopy at Amsterdam University Medical Center.
Moreover, he added, “this technique is disease-modifying, so it goes to the root cause of type 2 diabetes and tackles the insulin resistance, as opposed to drug therapy, which at best, is disease-controlling, and the effect is immediately gone if you stop the medication.”
ReCET is similar to another product, Fractyl’s Revita DMR, for which Dr. Bergman was involved in a randomized clinical trial. He said in an interview that the two technologies differ in that the Revita uses heat with submucosal lifting to avoid deeper heat penetration, whereas ReCET is nonthermal. He is also involved in a second randomized trial of the Revita.
Is semaglutide muddying the findings?
Asked to comment about the current study with ReCET, Ali Aminian, MD, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic, said that the treatment effect is certainly plausible.
“The observation that hyperglycemia rapidly and substantially improves after bariatric surgery has prompted innovators to search for novel endoscopic procedures targeting the GI tract to improve diabetes and metabolic disease. Over the years, we learned that in addition to its role in digestion and absorption, the GI tract is actually a large endocrine organ which contributes to development of diabetes and metabolic disease.”
However, Dr. Aminian said that, “while these preliminary findings on a very small number of patients with a very short follow-up time are interesting,” he faulted the study design for including semaglutide. “When patients are treated with a combination of therapies, it will be hard to understand the true effect of each therapy,” and particularly, “when we add a strong diabetes medication like semaglutide.”
Dr. Bergman said semaglutide was used to “boost the insulin-resistant effect of the endoscopic treatment,” and that a planned double-blind, randomized trial will “show how much semaglutide actually contributed to the effect.” The ultimate goal, he noted, is to eliminate the need for all medications.
Moreover, when people with type 2 diabetes add semaglutide to insulin treatment, only about 20% typically are able to quit taking the insulin, in contrast to the 86% seen in this study, lead author Celine Busch, MBBS, a PhD candidate in gastroenterology at Amsterdam University, said in a DDW statement.
Dr. Aminian said, “I’m looking forward to better quality data ... from studies with a stronger design to prove safety, efficacy, and durability of this endoscopic intervention in patients with diabetes.”
But, he also cautioned, “in the past few years, other endoscopic procedures targeting the duodenum were introduced with exciting initial findings based on a small series [with a] short-term follow-up time. However, their safety, efficacy, and durability were not proven in subsequent studies.”
All patients stopped insulin, most for a year
The single-arm, single-center study involved 14 patients with type 2 diabetes taking basal but not premeal insulin. All underwent the 1-hour outpatient ReCET procedure, which involved placing a catheter into the first part of the small bowel and delivering electrical pulses to the duodenum.
Patients adhered to a calorie-controlled liquid diet for 2 weeks, after which they were initiated on semaglutide. All 14 patients were able to come off insulin for 3 months while maintaining glycemic control, and 12 were able to come off insulin for 12 months. They also experienced a 50% reduction in liver fat.
Dr. Bergman said a randomized, double-blind study using a sham procedure for controls is expected to start in about 2 months. “But for now, we are very encouraged by the potential for controlling type 2 diabetes with a single endoscopic treatment.”
Dr. Bergman has reported serving on the advisory board for Endogenex. Dr. Aminian has reported receiving research support and honorarium from Medtronic and Ethicon.
The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.
A version of this article first appeared on Medscape.com.
Called recellularization via electroporation therapy (ReCET), the technology, manufactured by Endogenex, uses a specialized catheter to deliver alternating electric pulses to the duodenum to induce cellular regeneration. This process is thought to improve insulin sensitivity, in part, by altering gut hormones and nutritional sensing, principal investigator Jacques Bergman, MD, PhD, said in a press briefing held in conjunction with the annual Digestive Disease Week® (DDW), where he will present the data on May 9.
In the first-in-human study of ReCET, 12 of 14 patients were able to come off insulin for up to a year following the procedure when combined with the use of the glucagonlike peptide–1 agonist semaglutide.
“This might be a game changer in the management of type 2 diabetes because a single outpatient endoscopic intervention was suggested to have a pretty long therapeutic effect, which is compliance-free, as opposed to drug therapy that relies on patients taking the drugs on a daily basis,” said Dr. Bergman, professor of gastrointestinal endoscopy at Amsterdam University Medical Center.
Moreover, he added, “this technique is disease-modifying, so it goes to the root cause of type 2 diabetes and tackles the insulin resistance, as opposed to drug therapy, which at best, is disease-controlling, and the effect is immediately gone if you stop the medication.”
ReCET is similar to another product, Fractyl’s Revita DMR, for which Dr. Bergman was involved in a randomized clinical trial. He said in an interview that the two technologies differ in that the Revita uses heat with submucosal lifting to avoid deeper heat penetration, whereas ReCET is nonthermal. He is also involved in a second randomized trial of the Revita.
Is semaglutide muddying the findings?
Asked to comment about the current study with ReCET, Ali Aminian, MD, professor of surgery and director of the Bariatric and Metabolic Institute at the Cleveland Clinic, said that the treatment effect is certainly plausible.
“The observation that hyperglycemia rapidly and substantially improves after bariatric surgery has prompted innovators to search for novel endoscopic procedures targeting the GI tract to improve diabetes and metabolic disease. Over the years, we learned that in addition to its role in digestion and absorption, the GI tract is actually a large endocrine organ which contributes to development of diabetes and metabolic disease.”
However, Dr. Aminian said that, “while these preliminary findings on a very small number of patients with a very short follow-up time are interesting,” he faulted the study design for including semaglutide. “When patients are treated with a combination of therapies, it will be hard to understand the true effect of each therapy,” and particularly, “when we add a strong diabetes medication like semaglutide.”
Dr. Bergman said semaglutide was used to “boost the insulin-resistant effect of the endoscopic treatment,” and that a planned double-blind, randomized trial will “show how much semaglutide actually contributed to the effect.” The ultimate goal, he noted, is to eliminate the need for all medications.
Moreover, when people with type 2 diabetes add semaglutide to insulin treatment, only about 20% typically are able to quit taking the insulin, in contrast to the 86% seen in this study, lead author Celine Busch, MBBS, a PhD candidate in gastroenterology at Amsterdam University, said in a DDW statement.
Dr. Aminian said, “I’m looking forward to better quality data ... from studies with a stronger design to prove safety, efficacy, and durability of this endoscopic intervention in patients with diabetes.”
But, he also cautioned, “in the past few years, other endoscopic procedures targeting the duodenum were introduced with exciting initial findings based on a small series [with a] short-term follow-up time. However, their safety, efficacy, and durability were not proven in subsequent studies.”
All patients stopped insulin, most for a year
The single-arm, single-center study involved 14 patients with type 2 diabetes taking basal but not premeal insulin. All underwent the 1-hour outpatient ReCET procedure, which involved placing a catheter into the first part of the small bowel and delivering electrical pulses to the duodenum.
Patients adhered to a calorie-controlled liquid diet for 2 weeks, after which they were initiated on semaglutide. All 14 patients were able to come off insulin for 3 months while maintaining glycemic control, and 12 were able to come off insulin for 12 months. They also experienced a 50% reduction in liver fat.
Dr. Bergman said a randomized, double-blind study using a sham procedure for controls is expected to start in about 2 months. “But for now, we are very encouraged by the potential for controlling type 2 diabetes with a single endoscopic treatment.”
Dr. Bergman has reported serving on the advisory board for Endogenex. Dr. Aminian has reported receiving research support and honorarium from Medtronic and Ethicon.
The meeting is sponsored by the American Gastroenterological Association, the American Association for the Study of Liver Diseases, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.
A version of this article first appeared on Medscape.com.
FROM DDW 2023
Seasonal variation in thyroid hormone TSH may lead to overprescribing
Seasonal variation in one of the hormones used to monitor thyroid function could in turn lead to false diagnoses of subclinical hypothyroidism and unnecessary prescriptions of levothyroxine, according to Yale clinical chemist Joe M. El-Khoury, PhD.
A Japanese study of more than 7,000 healthy individuals showed that thyrotropin-stimulating hormone (TSH) varies widely throughout the seasons, he said, peaking in the northern hemisphere’s winter months (January to February) with its low in the summer months (June to August). That paper was published last year in the Journal of the Endocrine Society.
But free thyroxine (FT4) levels in the Japanese population remained relatively stable, he wrote in a letter recently published in Clinical Chemistry.
“If you end up with a mildly elevated TSH result and a normal FT4, try getting retested 2-3 months later to make sure this is not a seasonal artifact or transient increase before prescribing/taking levothyroxine unnecessarily,” advised Dr. El-Khoury, director of Yale University’s Clinical Chemistry Laboratory, New Haven, Conn.
“Because the [population-based, laboratory] reference ranges don’t account for seasonal variation, we’re flagging a significant number of people as high TSH when they’re normal, and physicians are prescribing levothyroxine inappropriately to healthy people who don’t need it,” he told this news organization, adding that overtreatment can be harmful, particularly for elderly people.
This seasonal variation in TSH could account for between a third to a half of the 90% of all levothyroxine prescriptions that were found to be unnecessary, according to a U.S. study in 2021, Dr. El-Khoury added.
In a comment, Trisha Cubb, MD, said that Dr. El-Khoury’s letter “raises a good point, that we really need to look at our reference ranges, especially when more and more studies are showing that so many thyroid hormone prescriptions may not be necessary.”
Dr. Cubb, thyroid section director and assistant professor of clinical medicine at Weill Cornell Medical College/Houston Methodist Academic Institute, Texas, also agrees with Dr. El-Khoury’s suggestion to repeat lab results in some instances.
“I think repeating results, especially in our patients with subclinical disease, is important,” she noted.
And she pointed out that seasonal variation isn’t the only relevant variable. “We also know that multiple clinical factors like pregnancy status, coexisting comorbidities, or age can all influence what we as clinicians consider an acceptable TSH range in an individual patient.” And other medications, such as steroids, or supplements like biotin, “can all affect thyroid lab values,” she noted.
“Ensuring that minor abnormalities aren’t transient is important prior to initiating medical therapy. With any medical therapy there are possible side effects, along with time, cost, [and] monitoring, all of which can be associated with thyroid hormone replacement.”
TSH reference ranges should be adapted for subpopulations
Dr. El-Khoury explained that to get an idea of how big the seasonal differences in TSH observed in the Japanese study were, “the upper end of the population they tracked goes from 5.2 [mIU/L] in January to 3.4 [mIU/L] in August. So you have almost a 2-unit change in concentration that can happen in the reference population. But laboratory reference ranges, or ‘normal ranges,’ are usually fixed and don’t change by season.”
The higher the TSH, the more likely a person is to have hypothyroidism. Major recent studies have found no benefit of levothyroxine treatment with TSH levels below 7.0-10.0 mIU/L, he said.
“So, I suggest that the limit should be 7.0 [mIU/L] to be safe, but it could be as high as 10 [mIU/L]. In any case, let’s shift the mindset to clinical outcome–based treatment cutoffs,” he said, noting that this approach is currently used for decisions on cholesterol-lowering therapy or vitamin D supplementation, for example.
Regarding this suggestion of using a TSH cutoff of 7 mIU/L to diagnose subclinical hypothyroidism, Dr. Cubb said: “It really depends on the specific population. In an elderly patient, a higher TSH may be of less clinical concern when compared to a female who is actively trying to get pregnant.
“Overall, I think we do need to better understand what appropriate TSH ranges are in specific subpopulations, and then with time, make this more understandable and available for general medicine as well as subspecialty providers to be able to utilize,” she noted.
Regarding the particular Japanese findings cited by Dr. El-Khoury, Dr. Cubb observed that this was a very specific study population, “so we would need more data showing that this is more generalizable.”
And she noted that there’s also diurnal variation in TSH. “In the [Japanese] paper, patients had their thyroid labs drawn between 8:00 a.m. and 9:00 a.m. in a fasting state. Oftentimes in the U.S., thyroid labs are not drawn at specific times or [during] fasting. I think this is one of many factors that should be considered.”
Acknowledging seasonal variation would be a start
But overall, Dr. Cubb said that both the Japanese study and Dr. El-Khoury’s letter highlight “how season, in and of itself, which is not something we usually think about, can affect thyroid lab results. I believe as more data come out, more generalizable data, that’s how evidence-based guidelines are generated over time.”
According to Dr. El-Khoury, fixing the laboratory reference range issues would likely require a joint effort of professional medical societies, reference laboratories, and assay manufacturers. But with seasonal variation, that might be a difficult task.
“The problem is, in laboratory medicine, we don’t have rules for an analyte that changes by season to do anything different. My goal is to get people to at least acknowledge this is a problem and do something,” he concluded.
Dr. El-Khoury and Dr. Cubb have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Seasonal variation in one of the hormones used to monitor thyroid function could in turn lead to false diagnoses of subclinical hypothyroidism and unnecessary prescriptions of levothyroxine, according to Yale clinical chemist Joe M. El-Khoury, PhD.
A Japanese study of more than 7,000 healthy individuals showed that thyrotropin-stimulating hormone (TSH) varies widely throughout the seasons, he said, peaking in the northern hemisphere’s winter months (January to February) with its low in the summer months (June to August). That paper was published last year in the Journal of the Endocrine Society.
But free thyroxine (FT4) levels in the Japanese population remained relatively stable, he wrote in a letter recently published in Clinical Chemistry.
“If you end up with a mildly elevated TSH result and a normal FT4, try getting retested 2-3 months later to make sure this is not a seasonal artifact or transient increase before prescribing/taking levothyroxine unnecessarily,” advised Dr. El-Khoury, director of Yale University’s Clinical Chemistry Laboratory, New Haven, Conn.
“Because the [population-based, laboratory] reference ranges don’t account for seasonal variation, we’re flagging a significant number of people as high TSH when they’re normal, and physicians are prescribing levothyroxine inappropriately to healthy people who don’t need it,” he told this news organization, adding that overtreatment can be harmful, particularly for elderly people.
This seasonal variation in TSH could account for between a third to a half of the 90% of all levothyroxine prescriptions that were found to be unnecessary, according to a U.S. study in 2021, Dr. El-Khoury added.
In a comment, Trisha Cubb, MD, said that Dr. El-Khoury’s letter “raises a good point, that we really need to look at our reference ranges, especially when more and more studies are showing that so many thyroid hormone prescriptions may not be necessary.”
Dr. Cubb, thyroid section director and assistant professor of clinical medicine at Weill Cornell Medical College/Houston Methodist Academic Institute, Texas, also agrees with Dr. El-Khoury’s suggestion to repeat lab results in some instances.
“I think repeating results, especially in our patients with subclinical disease, is important,” she noted.
And she pointed out that seasonal variation isn’t the only relevant variable. “We also know that multiple clinical factors like pregnancy status, coexisting comorbidities, or age can all influence what we as clinicians consider an acceptable TSH range in an individual patient.” And other medications, such as steroids, or supplements like biotin, “can all affect thyroid lab values,” she noted.
“Ensuring that minor abnormalities aren’t transient is important prior to initiating medical therapy. With any medical therapy there are possible side effects, along with time, cost, [and] monitoring, all of which can be associated with thyroid hormone replacement.”
TSH reference ranges should be adapted for subpopulations
Dr. El-Khoury explained that to get an idea of how big the seasonal differences in TSH observed in the Japanese study were, “the upper end of the population they tracked goes from 5.2 [mIU/L] in January to 3.4 [mIU/L] in August. So you have almost a 2-unit change in concentration that can happen in the reference population. But laboratory reference ranges, or ‘normal ranges,’ are usually fixed and don’t change by season.”
The higher the TSH, the more likely a person is to have hypothyroidism. Major recent studies have found no benefit of levothyroxine treatment with TSH levels below 7.0-10.0 mIU/L, he said.
“So, I suggest that the limit should be 7.0 [mIU/L] to be safe, but it could be as high as 10 [mIU/L]. In any case, let’s shift the mindset to clinical outcome–based treatment cutoffs,” he said, noting that this approach is currently used for decisions on cholesterol-lowering therapy or vitamin D supplementation, for example.
Regarding this suggestion of using a TSH cutoff of 7 mIU/L to diagnose subclinical hypothyroidism, Dr. Cubb said: “It really depends on the specific population. In an elderly patient, a higher TSH may be of less clinical concern when compared to a female who is actively trying to get pregnant.
“Overall, I think we do need to better understand what appropriate TSH ranges are in specific subpopulations, and then with time, make this more understandable and available for general medicine as well as subspecialty providers to be able to utilize,” she noted.
Regarding the particular Japanese findings cited by Dr. El-Khoury, Dr. Cubb observed that this was a very specific study population, “so we would need more data showing that this is more generalizable.”
And she noted that there’s also diurnal variation in TSH. “In the [Japanese] paper, patients had their thyroid labs drawn between 8:00 a.m. and 9:00 a.m. in a fasting state. Oftentimes in the U.S., thyroid labs are not drawn at specific times or [during] fasting. I think this is one of many factors that should be considered.”
Acknowledging seasonal variation would be a start
But overall, Dr. Cubb said that both the Japanese study and Dr. El-Khoury’s letter highlight “how season, in and of itself, which is not something we usually think about, can affect thyroid lab results. I believe as more data come out, more generalizable data, that’s how evidence-based guidelines are generated over time.”
According to Dr. El-Khoury, fixing the laboratory reference range issues would likely require a joint effort of professional medical societies, reference laboratories, and assay manufacturers. But with seasonal variation, that might be a difficult task.
“The problem is, in laboratory medicine, we don’t have rules for an analyte that changes by season to do anything different. My goal is to get people to at least acknowledge this is a problem and do something,” he concluded.
Dr. El-Khoury and Dr. Cubb have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Seasonal variation in one of the hormones used to monitor thyroid function could in turn lead to false diagnoses of subclinical hypothyroidism and unnecessary prescriptions of levothyroxine, according to Yale clinical chemist Joe M. El-Khoury, PhD.
A Japanese study of more than 7,000 healthy individuals showed that thyrotropin-stimulating hormone (TSH) varies widely throughout the seasons, he said, peaking in the northern hemisphere’s winter months (January to February) with its low in the summer months (June to August). That paper was published last year in the Journal of the Endocrine Society.
But free thyroxine (FT4) levels in the Japanese population remained relatively stable, he wrote in a letter recently published in Clinical Chemistry.
“If you end up with a mildly elevated TSH result and a normal FT4, try getting retested 2-3 months later to make sure this is not a seasonal artifact or transient increase before prescribing/taking levothyroxine unnecessarily,” advised Dr. El-Khoury, director of Yale University’s Clinical Chemistry Laboratory, New Haven, Conn.
“Because the [population-based, laboratory] reference ranges don’t account for seasonal variation, we’re flagging a significant number of people as high TSH when they’re normal, and physicians are prescribing levothyroxine inappropriately to healthy people who don’t need it,” he told this news organization, adding that overtreatment can be harmful, particularly for elderly people.
This seasonal variation in TSH could account for between a third to a half of the 90% of all levothyroxine prescriptions that were found to be unnecessary, according to a U.S. study in 2021, Dr. El-Khoury added.
In a comment, Trisha Cubb, MD, said that Dr. El-Khoury’s letter “raises a good point, that we really need to look at our reference ranges, especially when more and more studies are showing that so many thyroid hormone prescriptions may not be necessary.”
Dr. Cubb, thyroid section director and assistant professor of clinical medicine at Weill Cornell Medical College/Houston Methodist Academic Institute, Texas, also agrees with Dr. El-Khoury’s suggestion to repeat lab results in some instances.
“I think repeating results, especially in our patients with subclinical disease, is important,” she noted.
And she pointed out that seasonal variation isn’t the only relevant variable. “We also know that multiple clinical factors like pregnancy status, coexisting comorbidities, or age can all influence what we as clinicians consider an acceptable TSH range in an individual patient.” And other medications, such as steroids, or supplements like biotin, “can all affect thyroid lab values,” she noted.
“Ensuring that minor abnormalities aren’t transient is important prior to initiating medical therapy. With any medical therapy there are possible side effects, along with time, cost, [and] monitoring, all of which can be associated with thyroid hormone replacement.”
TSH reference ranges should be adapted for subpopulations
Dr. El-Khoury explained that to get an idea of how big the seasonal differences in TSH observed in the Japanese study were, “the upper end of the population they tracked goes from 5.2 [mIU/L] in January to 3.4 [mIU/L] in August. So you have almost a 2-unit change in concentration that can happen in the reference population. But laboratory reference ranges, or ‘normal ranges,’ are usually fixed and don’t change by season.”
The higher the TSH, the more likely a person is to have hypothyroidism. Major recent studies have found no benefit of levothyroxine treatment with TSH levels below 7.0-10.0 mIU/L, he said.
“So, I suggest that the limit should be 7.0 [mIU/L] to be safe, but it could be as high as 10 [mIU/L]. In any case, let’s shift the mindset to clinical outcome–based treatment cutoffs,” he said, noting that this approach is currently used for decisions on cholesterol-lowering therapy or vitamin D supplementation, for example.
Regarding this suggestion of using a TSH cutoff of 7 mIU/L to diagnose subclinical hypothyroidism, Dr. Cubb said: “It really depends on the specific population. In an elderly patient, a higher TSH may be of less clinical concern when compared to a female who is actively trying to get pregnant.
“Overall, I think we do need to better understand what appropriate TSH ranges are in specific subpopulations, and then with time, make this more understandable and available for general medicine as well as subspecialty providers to be able to utilize,” she noted.
Regarding the particular Japanese findings cited by Dr. El-Khoury, Dr. Cubb observed that this was a very specific study population, “so we would need more data showing that this is more generalizable.”
And she noted that there’s also diurnal variation in TSH. “In the [Japanese] paper, patients had their thyroid labs drawn between 8:00 a.m. and 9:00 a.m. in a fasting state. Oftentimes in the U.S., thyroid labs are not drawn at specific times or [during] fasting. I think this is one of many factors that should be considered.”
Acknowledging seasonal variation would be a start
But overall, Dr. Cubb said that both the Japanese study and Dr. El-Khoury’s letter highlight “how season, in and of itself, which is not something we usually think about, can affect thyroid lab results. I believe as more data come out, more generalizable data, that’s how evidence-based guidelines are generated over time.”
According to Dr. El-Khoury, fixing the laboratory reference range issues would likely require a joint effort of professional medical societies, reference laboratories, and assay manufacturers. But with seasonal variation, that might be a difficult task.
“The problem is, in laboratory medicine, we don’t have rules for an analyte that changes by season to do anything different. My goal is to get people to at least acknowledge this is a problem and do something,” he concluded.
Dr. El-Khoury and Dr. Cubb have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CLINICAL CHEMISTRY
FDA okays latest artificial pancreas, the MiniMed 780G
The Food and Drug Administration has approved Medtronic Minimed’s 780G automated insulin delivery system with the Guardian 4 sensor.
The latest so-called artificial pancreas system is approved for people aged 7 years and older who have type 1 diabetes. Medtronic will begin taking preorders for the 780G on May 15, 2023. Users of the current MiniMed 770G will be eligible for no-cost remote software upgrades.
The 780G is currently available in 105 countries. It has been available in Europe since 2020 and in the United Kingdom since 2021. It is the first automated insulin delivery system to automatically administer bolus correction insulin doses every 5 minutes to correct meal-related hyperglycemia.
This so-called meal detection technology doesn’t replace manual premeal boluses but does provide extra insulin if the premeal bolus is skipped or is insufficient.
As with other automated systems, the 780G automatically adjusts basal insulin doses up or down based on glucose levels and trends and shuts off insulin delivery to prevent hypoglycemia. The insulin pump’s infusion set can be worn for 7 days, rather than 3 days as with the older system, and the glucose target level can be set as low as 100 mg/dL.
And in contrast to the older MiniMed 670G system, which tended to frequently boot users out of automated mode, with the 780G, users spent an average of 95% of the time in the automated “SmartGuard” mode.
In the pivotal U.S. trial, overall, patients who used the 780G spent 75% of the time in ideal glucose range (70-180 mg/dL) and 1.8% of the time below that range. Overnight, the figures were 82% and 1.5%, respectively. With the glucose target set at 100 mg/dL and active insulin time set to 2 hours, patients spent 78.8% of time in range without increased hyperglycemia.
In the ADAPT study, with the 780G, there was a 26% increase in time in ideal glucose range and a 1.4% reduction in A1c compared with results for patients who received multiple daily insulin injections with intermittently scanned continuous glucose monitoring, without an increase in hypoglycemia. Overnight, time in range increased 30.2%. The results were sustained at 1 year.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved Medtronic Minimed’s 780G automated insulin delivery system with the Guardian 4 sensor.
The latest so-called artificial pancreas system is approved for people aged 7 years and older who have type 1 diabetes. Medtronic will begin taking preorders for the 780G on May 15, 2023. Users of the current MiniMed 770G will be eligible for no-cost remote software upgrades.
The 780G is currently available in 105 countries. It has been available in Europe since 2020 and in the United Kingdom since 2021. It is the first automated insulin delivery system to automatically administer bolus correction insulin doses every 5 minutes to correct meal-related hyperglycemia.
This so-called meal detection technology doesn’t replace manual premeal boluses but does provide extra insulin if the premeal bolus is skipped or is insufficient.
As with other automated systems, the 780G automatically adjusts basal insulin doses up or down based on glucose levels and trends and shuts off insulin delivery to prevent hypoglycemia. The insulin pump’s infusion set can be worn for 7 days, rather than 3 days as with the older system, and the glucose target level can be set as low as 100 mg/dL.
And in contrast to the older MiniMed 670G system, which tended to frequently boot users out of automated mode, with the 780G, users spent an average of 95% of the time in the automated “SmartGuard” mode.
In the pivotal U.S. trial, overall, patients who used the 780G spent 75% of the time in ideal glucose range (70-180 mg/dL) and 1.8% of the time below that range. Overnight, the figures were 82% and 1.5%, respectively. With the glucose target set at 100 mg/dL and active insulin time set to 2 hours, patients spent 78.8% of time in range without increased hyperglycemia.
In the ADAPT study, with the 780G, there was a 26% increase in time in ideal glucose range and a 1.4% reduction in A1c compared with results for patients who received multiple daily insulin injections with intermittently scanned continuous glucose monitoring, without an increase in hypoglycemia. Overnight, time in range increased 30.2%. The results were sustained at 1 year.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved Medtronic Minimed’s 780G automated insulin delivery system with the Guardian 4 sensor.
The latest so-called artificial pancreas system is approved for people aged 7 years and older who have type 1 diabetes. Medtronic will begin taking preorders for the 780G on May 15, 2023. Users of the current MiniMed 770G will be eligible for no-cost remote software upgrades.
The 780G is currently available in 105 countries. It has been available in Europe since 2020 and in the United Kingdom since 2021. It is the first automated insulin delivery system to automatically administer bolus correction insulin doses every 5 minutes to correct meal-related hyperglycemia.
This so-called meal detection technology doesn’t replace manual premeal boluses but does provide extra insulin if the premeal bolus is skipped or is insufficient.
As with other automated systems, the 780G automatically adjusts basal insulin doses up or down based on glucose levels and trends and shuts off insulin delivery to prevent hypoglycemia. The insulin pump’s infusion set can be worn for 7 days, rather than 3 days as with the older system, and the glucose target level can be set as low as 100 mg/dL.
And in contrast to the older MiniMed 670G system, which tended to frequently boot users out of automated mode, with the 780G, users spent an average of 95% of the time in the automated “SmartGuard” mode.
In the pivotal U.S. trial, overall, patients who used the 780G spent 75% of the time in ideal glucose range (70-180 mg/dL) and 1.8% of the time below that range. Overnight, the figures were 82% and 1.5%, respectively. With the glucose target set at 100 mg/dL and active insulin time set to 2 hours, patients spent 78.8% of time in range without increased hyperglycemia.
In the ADAPT study, with the 780G, there was a 26% increase in time in ideal glucose range and a 1.4% reduction in A1c compared with results for patients who received multiple daily insulin injections with intermittently scanned continuous glucose monitoring, without an increase in hypoglycemia. Overnight, time in range increased 30.2%. The results were sustained at 1 year.
A version of this article first appeared on Medscape.com.
Medicare expands CGM coverage to more with type 2 diabetes
Medicare is now covering continuous glucose monitoring (CGM) for all beneficiaries with diabetes who use insulin, as well as those with a “history of problematic hypoglycemia.”
The new policy decision, announced earlier this year by the Centers for Medicare and Medicaid Services, means that coverage is expanded to those who take even just a single dose of basal insulin daily or who don’t take insulin but who for other reasons experience “problematic” hypoglycemia, defined as a history of more than one level 2 event (glucose < 54 mg/dL) or at least one level 3 event (< 54 mg/dL requiring assistance).
Previously, coverage was limited to those taking frequent daily insulin doses.
The additional number of people covered, most with type 2 diabetes, is estimated to be at least 1.5 million. That number could more than double if private insurers follow suit, reported an industry analyst.
Chuck Henderson, chief executive officer of the American Diabetes Association, said in a statement: “We applaud CMS’ decision allowing for all insulin-dependent people as well as others who have a history of problematic hypoglycemia to have access to a continuous glucose monitor, a potentially life-saving tool for diabetes management.”
According to Dexcom, which manufacturers the G6 and the recently approved G7 CGMs, the decision was based in part on their MOBILE study. The trial demonstrated the benefit of CGM in people with type 2 diabetes who use only basal insulin or have a history of problematic hypoglycemic events.
On April 14, Abbott, which manufactures the Freestyle Libre 2 and the recently approved Libre 3, received clearance from the U.S. Food and Drug Administration for the Libre 3’s stand-alone reader device. Previously, the Libre 3 had been approved for use only with a smartphone app. The small handheld reader is considered durable medical equipment, making it eligible for Medicare coverage. Abbott is “working on having the FreeStyle Libre 3 system available to Medicare beneficiaries,” the company said in a statement.
A version of this article first appeared on Medscape.com.
Medicare is now covering continuous glucose monitoring (CGM) for all beneficiaries with diabetes who use insulin, as well as those with a “history of problematic hypoglycemia.”
The new policy decision, announced earlier this year by the Centers for Medicare and Medicaid Services, means that coverage is expanded to those who take even just a single dose of basal insulin daily or who don’t take insulin but who for other reasons experience “problematic” hypoglycemia, defined as a history of more than one level 2 event (glucose < 54 mg/dL) or at least one level 3 event (< 54 mg/dL requiring assistance).
Previously, coverage was limited to those taking frequent daily insulin doses.
The additional number of people covered, most with type 2 diabetes, is estimated to be at least 1.5 million. That number could more than double if private insurers follow suit, reported an industry analyst.
Chuck Henderson, chief executive officer of the American Diabetes Association, said in a statement: “We applaud CMS’ decision allowing for all insulin-dependent people as well as others who have a history of problematic hypoglycemia to have access to a continuous glucose monitor, a potentially life-saving tool for diabetes management.”
According to Dexcom, which manufacturers the G6 and the recently approved G7 CGMs, the decision was based in part on their MOBILE study. The trial demonstrated the benefit of CGM in people with type 2 diabetes who use only basal insulin or have a history of problematic hypoglycemic events.
On April 14, Abbott, which manufactures the Freestyle Libre 2 and the recently approved Libre 3, received clearance from the U.S. Food and Drug Administration for the Libre 3’s stand-alone reader device. Previously, the Libre 3 had been approved for use only with a smartphone app. The small handheld reader is considered durable medical equipment, making it eligible for Medicare coverage. Abbott is “working on having the FreeStyle Libre 3 system available to Medicare beneficiaries,” the company said in a statement.
A version of this article first appeared on Medscape.com.
Medicare is now covering continuous glucose monitoring (CGM) for all beneficiaries with diabetes who use insulin, as well as those with a “history of problematic hypoglycemia.”
The new policy decision, announced earlier this year by the Centers for Medicare and Medicaid Services, means that coverage is expanded to those who take even just a single dose of basal insulin daily or who don’t take insulin but who for other reasons experience “problematic” hypoglycemia, defined as a history of more than one level 2 event (glucose < 54 mg/dL) or at least one level 3 event (< 54 mg/dL requiring assistance).
Previously, coverage was limited to those taking frequent daily insulin doses.
The additional number of people covered, most with type 2 diabetes, is estimated to be at least 1.5 million. That number could more than double if private insurers follow suit, reported an industry analyst.
Chuck Henderson, chief executive officer of the American Diabetes Association, said in a statement: “We applaud CMS’ decision allowing for all insulin-dependent people as well as others who have a history of problematic hypoglycemia to have access to a continuous glucose monitor, a potentially life-saving tool for diabetes management.”
According to Dexcom, which manufacturers the G6 and the recently approved G7 CGMs, the decision was based in part on their MOBILE study. The trial demonstrated the benefit of CGM in people with type 2 diabetes who use only basal insulin or have a history of problematic hypoglycemic events.
On April 14, Abbott, which manufactures the Freestyle Libre 2 and the recently approved Libre 3, received clearance from the U.S. Food and Drug Administration for the Libre 3’s stand-alone reader device. Previously, the Libre 3 had been approved for use only with a smartphone app. The small handheld reader is considered durable medical equipment, making it eligible for Medicare coverage. Abbott is “working on having the FreeStyle Libre 3 system available to Medicare beneficiaries,” the company said in a statement.
A version of this article first appeared on Medscape.com.
Plant-based diets not always healthy; quality is key
The prospective cohort study used data from more than 120,000 middle-aged adults followed for over 10 years in the UK Biobank. Those who consumed a healthful plant-based diet – with higher amounts of foods such as fruits, vegetables, legumes, whole grains, and nuts – and lower intakes of animal products, sugary drinks, and refined grains had a 16% lower risk of dying during follow-up, compared with those with the lowest intakes of the healthful plant-based foods.
By contrast, an unhealthy plant-based diet was associated with a 23% higher total mortality risk.
“Not all plant-based diets are created equally. Our data provide evidence to support the notion that for health benefits the plant-based sources need to be whole grains, fruits and vegetables, legumes, nuts, etc., rather than processed plant-based foods,” study coauthor Aedín Cassidy, PhD, of Queen’s University, Belfast, Northern Ireland, said in an interview.
She added: “We do not necessarily need to radically shift diets to vegan or vegetarian regimens, but rather to switch proportions on the plate to incorporate more healthful plant-based foods, fish, and leaner cuts of meat into our habitual diet. This would have benefits for both individual health and planetary health.”
The findings were published online in JAMA Network Open by Alysha S. Thompson, MSc, also at Queen’s University, and colleagues.
High- vs. low-quality plant-based diets linked to better outcomes
The UK Biobank is a population-based, prospective study that included more than 500,000 participants aged 40-69 years at the time of recruitment between 2006 and 2010 at 22 centers in England, Scotland, and Wales. The current study included 126,395 individuals; slightly over half (55.9%) are women.
Food intake data were collected for at least two 24-hour periods to create both “healthful” and “unhealthful” plant-based diet indexes (PDIs). These included 17 food groups: whole grains, fruits, vegetables, nuts, legumes and vegetarian protein alternatives, tea and coffee, fruit juices, refined grains, potatoes, sugar-sweetened beverages, sweets and desserts, animal fat, dairy, eggs, fish or seafood, meat, and miscellaneous animal-derived foods. Data on oils weren’t available.
Higher scores on the healthful PDI and unhealthful PDI were scored positively or negatively based on quantities of those foods consumed.
Participants were then ranked in quartiles for portions of each food group and assigned scores between 2 (lowest-intake category) and 5 (highest).
During a follow-up of 10.6-12.2 years, there were 698 deaths attributed to cardiovascular disease, 3,275 deaths caused by cancer, 6,890 individuals who experienced a cardiovascular incident, and 8,939 with incident cancer.
Another 4,751 experienced an incident fracture, which was evaluated because of the concern that diets low in animal protein might lead to insufficient vitamin B and calcium intake.
After adjustment for confounding factors, the hazard ratio for all-cause mortality in individuals with the highest healthful PDI score quartile compared with the lowest quartile was 0.84.
At the same time, the HR for all-cause mortality for those with the highest versus lowest unhealthful PDI scores was 1.23, and for cancer-related mortality was 1.19. All were statistically significant (P = .004).
Similarly, greater healthy plant-based diet adherence was associated with a significantly lower risk of being diagnosed with any cancer (HR, 0.93; P = .03), while higher unhealthful PDI scores yielded a higher risk (HR, 1.10; P = .004).
Moreover, higher healthy PDI scores were associated with lower risks for total cardiovascular incident risks (HR, 0.92; P = .007), as well as for the individual events of ischemic stroke (HR, 0.84; P = .08) and MI (HR, 0.86; P = .004). Higher unhealthy PDI scores were similarly associated with greater risks for those outcomes, with an overall HR of 1.21 (P = .004).
No associations were found between either healthful PDI or unhealthful PDI and total or site-specific fracture risk.
And because 91.3% of the UK Biobank study population was White, “future studies among more racially, ethnically, and culturally diverse populations are needed to assess the risk of major chronic disease in relation to [plant-based diets],” the authors wrote.
Dr. Cassidy and Ms. Thompson reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The prospective cohort study used data from more than 120,000 middle-aged adults followed for over 10 years in the UK Biobank. Those who consumed a healthful plant-based diet – with higher amounts of foods such as fruits, vegetables, legumes, whole grains, and nuts – and lower intakes of animal products, sugary drinks, and refined grains had a 16% lower risk of dying during follow-up, compared with those with the lowest intakes of the healthful plant-based foods.
By contrast, an unhealthy plant-based diet was associated with a 23% higher total mortality risk.
“Not all plant-based diets are created equally. Our data provide evidence to support the notion that for health benefits the plant-based sources need to be whole grains, fruits and vegetables, legumes, nuts, etc., rather than processed plant-based foods,” study coauthor Aedín Cassidy, PhD, of Queen’s University, Belfast, Northern Ireland, said in an interview.
She added: “We do not necessarily need to radically shift diets to vegan or vegetarian regimens, but rather to switch proportions on the plate to incorporate more healthful plant-based foods, fish, and leaner cuts of meat into our habitual diet. This would have benefits for both individual health and planetary health.”
The findings were published online in JAMA Network Open by Alysha S. Thompson, MSc, also at Queen’s University, and colleagues.
High- vs. low-quality plant-based diets linked to better outcomes
The UK Biobank is a population-based, prospective study that included more than 500,000 participants aged 40-69 years at the time of recruitment between 2006 and 2010 at 22 centers in England, Scotland, and Wales. The current study included 126,395 individuals; slightly over half (55.9%) are women.
Food intake data were collected for at least two 24-hour periods to create both “healthful” and “unhealthful” plant-based diet indexes (PDIs). These included 17 food groups: whole grains, fruits, vegetables, nuts, legumes and vegetarian protein alternatives, tea and coffee, fruit juices, refined grains, potatoes, sugar-sweetened beverages, sweets and desserts, animal fat, dairy, eggs, fish or seafood, meat, and miscellaneous animal-derived foods. Data on oils weren’t available.
Higher scores on the healthful PDI and unhealthful PDI were scored positively or negatively based on quantities of those foods consumed.
Participants were then ranked in quartiles for portions of each food group and assigned scores between 2 (lowest-intake category) and 5 (highest).
During a follow-up of 10.6-12.2 years, there were 698 deaths attributed to cardiovascular disease, 3,275 deaths caused by cancer, 6,890 individuals who experienced a cardiovascular incident, and 8,939 with incident cancer.
Another 4,751 experienced an incident fracture, which was evaluated because of the concern that diets low in animal protein might lead to insufficient vitamin B and calcium intake.
After adjustment for confounding factors, the hazard ratio for all-cause mortality in individuals with the highest healthful PDI score quartile compared with the lowest quartile was 0.84.
At the same time, the HR for all-cause mortality for those with the highest versus lowest unhealthful PDI scores was 1.23, and for cancer-related mortality was 1.19. All were statistically significant (P = .004).
Similarly, greater healthy plant-based diet adherence was associated with a significantly lower risk of being diagnosed with any cancer (HR, 0.93; P = .03), while higher unhealthful PDI scores yielded a higher risk (HR, 1.10; P = .004).
Moreover, higher healthy PDI scores were associated with lower risks for total cardiovascular incident risks (HR, 0.92; P = .007), as well as for the individual events of ischemic stroke (HR, 0.84; P = .08) and MI (HR, 0.86; P = .004). Higher unhealthy PDI scores were similarly associated with greater risks for those outcomes, with an overall HR of 1.21 (P = .004).
No associations were found between either healthful PDI or unhealthful PDI and total or site-specific fracture risk.
And because 91.3% of the UK Biobank study population was White, “future studies among more racially, ethnically, and culturally diverse populations are needed to assess the risk of major chronic disease in relation to [plant-based diets],” the authors wrote.
Dr. Cassidy and Ms. Thompson reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The prospective cohort study used data from more than 120,000 middle-aged adults followed for over 10 years in the UK Biobank. Those who consumed a healthful plant-based diet – with higher amounts of foods such as fruits, vegetables, legumes, whole grains, and nuts – and lower intakes of animal products, sugary drinks, and refined grains had a 16% lower risk of dying during follow-up, compared with those with the lowest intakes of the healthful plant-based foods.
By contrast, an unhealthy plant-based diet was associated with a 23% higher total mortality risk.
“Not all plant-based diets are created equally. Our data provide evidence to support the notion that for health benefits the plant-based sources need to be whole grains, fruits and vegetables, legumes, nuts, etc., rather than processed plant-based foods,” study coauthor Aedín Cassidy, PhD, of Queen’s University, Belfast, Northern Ireland, said in an interview.
She added: “We do not necessarily need to radically shift diets to vegan or vegetarian regimens, but rather to switch proportions on the plate to incorporate more healthful plant-based foods, fish, and leaner cuts of meat into our habitual diet. This would have benefits for both individual health and planetary health.”
The findings were published online in JAMA Network Open by Alysha S. Thompson, MSc, also at Queen’s University, and colleagues.
High- vs. low-quality plant-based diets linked to better outcomes
The UK Biobank is a population-based, prospective study that included more than 500,000 participants aged 40-69 years at the time of recruitment between 2006 and 2010 at 22 centers in England, Scotland, and Wales. The current study included 126,395 individuals; slightly over half (55.9%) are women.
Food intake data were collected for at least two 24-hour periods to create both “healthful” and “unhealthful” plant-based diet indexes (PDIs). These included 17 food groups: whole grains, fruits, vegetables, nuts, legumes and vegetarian protein alternatives, tea and coffee, fruit juices, refined grains, potatoes, sugar-sweetened beverages, sweets and desserts, animal fat, dairy, eggs, fish or seafood, meat, and miscellaneous animal-derived foods. Data on oils weren’t available.
Higher scores on the healthful PDI and unhealthful PDI were scored positively or negatively based on quantities of those foods consumed.
Participants were then ranked in quartiles for portions of each food group and assigned scores between 2 (lowest-intake category) and 5 (highest).
During a follow-up of 10.6-12.2 years, there were 698 deaths attributed to cardiovascular disease, 3,275 deaths caused by cancer, 6,890 individuals who experienced a cardiovascular incident, and 8,939 with incident cancer.
Another 4,751 experienced an incident fracture, which was evaluated because of the concern that diets low in animal protein might lead to insufficient vitamin B and calcium intake.
After adjustment for confounding factors, the hazard ratio for all-cause mortality in individuals with the highest healthful PDI score quartile compared with the lowest quartile was 0.84.
At the same time, the HR for all-cause mortality for those with the highest versus lowest unhealthful PDI scores was 1.23, and for cancer-related mortality was 1.19. All were statistically significant (P = .004).
Similarly, greater healthy plant-based diet adherence was associated with a significantly lower risk of being diagnosed with any cancer (HR, 0.93; P = .03), while higher unhealthful PDI scores yielded a higher risk (HR, 1.10; P = .004).
Moreover, higher healthy PDI scores were associated with lower risks for total cardiovascular incident risks (HR, 0.92; P = .007), as well as for the individual events of ischemic stroke (HR, 0.84; P = .08) and MI (HR, 0.86; P = .004). Higher unhealthy PDI scores were similarly associated with greater risks for those outcomes, with an overall HR of 1.21 (P = .004).
No associations were found between either healthful PDI or unhealthful PDI and total or site-specific fracture risk.
And because 91.3% of the UK Biobank study population was White, “future studies among more racially, ethnically, and culturally diverse populations are needed to assess the risk of major chronic disease in relation to [plant-based diets],” the authors wrote.
Dr. Cassidy and Ms. Thompson reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Osteoporosis drugs may extend life after fracture
Long-term osteoporosis medications are associated with a reduced mortality risk following a fracture, new data suggest.
The findings, from nearly 50,000 individuals in a nationwide Taiwanese database from 2009 until 2018, suggest that alendronate/risedronate, denosumab, and zoledronic acid all result in a significantly lower mortality risk post fracture of 17%-22%, compared with raloxifene and bazedoxifene.
“Treatment for osteoporosis has the potential to minimize mortality risk in people of all ages and sexes for any type of fracture. The longer-acting treatments could lower mortality risk,” wrote Chih-Hsing Wu, MD, of the Institute of Gerontology at National Cheng Kung University, Tainan, Taiwan, and colleagues.
The findings have been published online in the Journal of Clinical Endocrinology and Metabolism.
Robert A. Adler, MD, who is chief of endocrinology at the Central Virginia Veterans Affairs Health Care System, Richmond, told this news organization that he hopes these new findings from a “really good database ... may be helpful in talking to a patient about the pros and cons of taking these drugs.”
“Patients have been made very fearful of the unusual side effects, particularly of the antiresorptive drugs,” which he notes include the rare adverse effects of jaw necrosis and atypical femoral fracture, which occur in about 1 per 10,000 patient-years.
“And because of that we have a hard time convincing people to want to take the drug in the first place or to stay on the drug once they start,” said Dr. Adler, who stressed that his viewpoints are his own and not representative of the VA.
“These data should help reinforce the advice already given in professional guidelines that their benefit outweighs any risks,” he stresses.
Dr. Adler also pointed out that both bisphosphonates included in the study, alendronate and zoledronic acid, are now available as generics and therefore inexpensive, but the latter can be subject to facility fees depending on where the infusion is delivered.
He added that hip fracture, in particular, triples the overall 1-year mortality risk in women aged 75-84 years and quadruples the risk in men. The study’s findings suggest that bisphosphonates, in particular, have pleiotropic effects beyond the bone; however, the underlying mechanisms are hard to determine.
“We don’t know all the reasons why people die after a fracture. These are older people who often have multiple medical problems, so it’s hard to dissect that out,” he said.
But whatever the mechanism for the salutary effect of the drugs, Dr. Adler said: “This is one other factor that might change people’s minds. You’re less likely to die. Well, that’s pretty good.”
‘Denosumab is a more potent antiresorptive than bisphosphonates’
Dr. Wu and colleagues analyzed data for individuals from Taiwan’s National Health Insurance Research Database. Between 2009 and 2017, 219,461 individuals had been newly diagnosed with an osteoporotic fracture. Of those, 46,729 were aged 40 and older and had been prescribed at least one anti-osteoporosis medication.
Participants were a mean age of 74.5 years, were 80% women, and 32% died during a mean follow-up of 4.7 years. The most commonly used anti-osteoporosis medications were the bisphosphonates alendronate or risedronate, followed by denosumab and the selective estrogen-receptor modulators (SERMs) daily oral raloxifene or bazedoxifene.
Patients treated with SERMs were used as the reference group because those drugs have been shown to have a neutral effect on mortality.
After adjustments, all but one of the medications had significantly lower mortality risks during follow-up, compared with raloxifene and bazedoxifene.
Compared with SERMs, at all fracture sites, the hazard ratios for mortality were 0.83 for alendronate/risedronate, 0.86 for denosumab, and 0.78 for zoledronic acid. Only ibandronate did not show the same protective effect.
Similar results were found for hip and vertebral fractures analyzed individually.
Women had a lower mortality risk than men.
Dr. Adler wrote an accompanying editorial for the article by Dr. Wu and colleagues.
Regarding the finding of benefit for denosumab, Dr. Adler notes: “I don’t know of another study that found denosumab leads to lower mortality. On the other hand, denosumab is a more potent antiresorptive than bisphosphonates.”
The study was funded by research grants from the Ministry of Science and Technology, Taiwan, partially supported by a research grant from the Taiwanese Osteoporosis Association and grants from National Cheng Kung University Hospital, Taiwan. Dr. Wu has reported receiving honoraria for lectures, attending meetings, and/or travel from Eli Lilly, Roche, Amgen, Merck, Servier, GE Lunar, Harvester, TCM Biotech, and Alvogen/Lotus. Dr. Adler has reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Long-term osteoporosis medications are associated with a reduced mortality risk following a fracture, new data suggest.
The findings, from nearly 50,000 individuals in a nationwide Taiwanese database from 2009 until 2018, suggest that alendronate/risedronate, denosumab, and zoledronic acid all result in a significantly lower mortality risk post fracture of 17%-22%, compared with raloxifene and bazedoxifene.
“Treatment for osteoporosis has the potential to minimize mortality risk in people of all ages and sexes for any type of fracture. The longer-acting treatments could lower mortality risk,” wrote Chih-Hsing Wu, MD, of the Institute of Gerontology at National Cheng Kung University, Tainan, Taiwan, and colleagues.
The findings have been published online in the Journal of Clinical Endocrinology and Metabolism.
Robert A. Adler, MD, who is chief of endocrinology at the Central Virginia Veterans Affairs Health Care System, Richmond, told this news organization that he hopes these new findings from a “really good database ... may be helpful in talking to a patient about the pros and cons of taking these drugs.”
“Patients have been made very fearful of the unusual side effects, particularly of the antiresorptive drugs,” which he notes include the rare adverse effects of jaw necrosis and atypical femoral fracture, which occur in about 1 per 10,000 patient-years.
“And because of that we have a hard time convincing people to want to take the drug in the first place or to stay on the drug once they start,” said Dr. Adler, who stressed that his viewpoints are his own and not representative of the VA.
“These data should help reinforce the advice already given in professional guidelines that their benefit outweighs any risks,” he stresses.
Dr. Adler also pointed out that both bisphosphonates included in the study, alendronate and zoledronic acid, are now available as generics and therefore inexpensive, but the latter can be subject to facility fees depending on where the infusion is delivered.
He added that hip fracture, in particular, triples the overall 1-year mortality risk in women aged 75-84 years and quadruples the risk in men. The study’s findings suggest that bisphosphonates, in particular, have pleiotropic effects beyond the bone; however, the underlying mechanisms are hard to determine.
“We don’t know all the reasons why people die after a fracture. These are older people who often have multiple medical problems, so it’s hard to dissect that out,” he said.
But whatever the mechanism for the salutary effect of the drugs, Dr. Adler said: “This is one other factor that might change people’s minds. You’re less likely to die. Well, that’s pretty good.”
‘Denosumab is a more potent antiresorptive than bisphosphonates’
Dr. Wu and colleagues analyzed data for individuals from Taiwan’s National Health Insurance Research Database. Between 2009 and 2017, 219,461 individuals had been newly diagnosed with an osteoporotic fracture. Of those, 46,729 were aged 40 and older and had been prescribed at least one anti-osteoporosis medication.
Participants were a mean age of 74.5 years, were 80% women, and 32% died during a mean follow-up of 4.7 years. The most commonly used anti-osteoporosis medications were the bisphosphonates alendronate or risedronate, followed by denosumab and the selective estrogen-receptor modulators (SERMs) daily oral raloxifene or bazedoxifene.
Patients treated with SERMs were used as the reference group because those drugs have been shown to have a neutral effect on mortality.
After adjustments, all but one of the medications had significantly lower mortality risks during follow-up, compared with raloxifene and bazedoxifene.
Compared with SERMs, at all fracture sites, the hazard ratios for mortality were 0.83 for alendronate/risedronate, 0.86 for denosumab, and 0.78 for zoledronic acid. Only ibandronate did not show the same protective effect.
Similar results were found for hip and vertebral fractures analyzed individually.
Women had a lower mortality risk than men.
Dr. Adler wrote an accompanying editorial for the article by Dr. Wu and colleagues.
Regarding the finding of benefit for denosumab, Dr. Adler notes: “I don’t know of another study that found denosumab leads to lower mortality. On the other hand, denosumab is a more potent antiresorptive than bisphosphonates.”
The study was funded by research grants from the Ministry of Science and Technology, Taiwan, partially supported by a research grant from the Taiwanese Osteoporosis Association and grants from National Cheng Kung University Hospital, Taiwan. Dr. Wu has reported receiving honoraria for lectures, attending meetings, and/or travel from Eli Lilly, Roche, Amgen, Merck, Servier, GE Lunar, Harvester, TCM Biotech, and Alvogen/Lotus. Dr. Adler has reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Long-term osteoporosis medications are associated with a reduced mortality risk following a fracture, new data suggest.
The findings, from nearly 50,000 individuals in a nationwide Taiwanese database from 2009 until 2018, suggest that alendronate/risedronate, denosumab, and zoledronic acid all result in a significantly lower mortality risk post fracture of 17%-22%, compared with raloxifene and bazedoxifene.
“Treatment for osteoporosis has the potential to minimize mortality risk in people of all ages and sexes for any type of fracture. The longer-acting treatments could lower mortality risk,” wrote Chih-Hsing Wu, MD, of the Institute of Gerontology at National Cheng Kung University, Tainan, Taiwan, and colleagues.
The findings have been published online in the Journal of Clinical Endocrinology and Metabolism.
Robert A. Adler, MD, who is chief of endocrinology at the Central Virginia Veterans Affairs Health Care System, Richmond, told this news organization that he hopes these new findings from a “really good database ... may be helpful in talking to a patient about the pros and cons of taking these drugs.”
“Patients have been made very fearful of the unusual side effects, particularly of the antiresorptive drugs,” which he notes include the rare adverse effects of jaw necrosis and atypical femoral fracture, which occur in about 1 per 10,000 patient-years.
“And because of that we have a hard time convincing people to want to take the drug in the first place or to stay on the drug once they start,” said Dr. Adler, who stressed that his viewpoints are his own and not representative of the VA.
“These data should help reinforce the advice already given in professional guidelines that their benefit outweighs any risks,” he stresses.
Dr. Adler also pointed out that both bisphosphonates included in the study, alendronate and zoledronic acid, are now available as generics and therefore inexpensive, but the latter can be subject to facility fees depending on where the infusion is delivered.
He added that hip fracture, in particular, triples the overall 1-year mortality risk in women aged 75-84 years and quadruples the risk in men. The study’s findings suggest that bisphosphonates, in particular, have pleiotropic effects beyond the bone; however, the underlying mechanisms are hard to determine.
“We don’t know all the reasons why people die after a fracture. These are older people who often have multiple medical problems, so it’s hard to dissect that out,” he said.
But whatever the mechanism for the salutary effect of the drugs, Dr. Adler said: “This is one other factor that might change people’s minds. You’re less likely to die. Well, that’s pretty good.”
‘Denosumab is a more potent antiresorptive than bisphosphonates’
Dr. Wu and colleagues analyzed data for individuals from Taiwan’s National Health Insurance Research Database. Between 2009 and 2017, 219,461 individuals had been newly diagnosed with an osteoporotic fracture. Of those, 46,729 were aged 40 and older and had been prescribed at least one anti-osteoporosis medication.
Participants were a mean age of 74.5 years, were 80% women, and 32% died during a mean follow-up of 4.7 years. The most commonly used anti-osteoporosis medications were the bisphosphonates alendronate or risedronate, followed by denosumab and the selective estrogen-receptor modulators (SERMs) daily oral raloxifene or bazedoxifene.
Patients treated with SERMs were used as the reference group because those drugs have been shown to have a neutral effect on mortality.
After adjustments, all but one of the medications had significantly lower mortality risks during follow-up, compared with raloxifene and bazedoxifene.
Compared with SERMs, at all fracture sites, the hazard ratios for mortality were 0.83 for alendronate/risedronate, 0.86 for denosumab, and 0.78 for zoledronic acid. Only ibandronate did not show the same protective effect.
Similar results were found for hip and vertebral fractures analyzed individually.
Women had a lower mortality risk than men.
Dr. Adler wrote an accompanying editorial for the article by Dr. Wu and colleagues.
Regarding the finding of benefit for denosumab, Dr. Adler notes: “I don’t know of another study that found denosumab leads to lower mortality. On the other hand, denosumab is a more potent antiresorptive than bisphosphonates.”
The study was funded by research grants from the Ministry of Science and Technology, Taiwan, partially supported by a research grant from the Taiwanese Osteoporosis Association and grants from National Cheng Kung University Hospital, Taiwan. Dr. Wu has reported receiving honoraria for lectures, attending meetings, and/or travel from Eli Lilly, Roche, Amgen, Merck, Servier, GE Lunar, Harvester, TCM Biotech, and Alvogen/Lotus. Dr. Adler has reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Tooth loss and diabetes together hasten mental decline
most specifically in those 65-74 years of age, new findings suggest.
The data come from a 12-year follow-up of older adults in a nationally representative U.S. survey.
“From a clinical perspective, our study demonstrates the importance of improving access to dental health care and integrating primary dental and medical care. Health care professionals and family caregivers should pay close attention to the cognitive status of diabetic older adults with poor oral health status,” lead author Bei Wu, PhD, of New York University, said in an interview. Dr. Wu is the Dean’s Professor in Global Health and codirector of the NYU Aging Incubator.
Moreover, said Dr. Wu: “For individuals with both poor oral health and diabetes, regular dental visits should be encouraged in addition to adherence to the diabetes self-care protocol.”
Diabetes has long been recognized as a risk factor for cognitive decline, but the findings have been inconsistent for different age groups. Tooth loss has also been linked to cognitive decline and dementia, as well as diabetes.
The mechanisms aren’t entirely clear, but “co-occurring diabetes and poor oral health may increase the risk for dementia, possibly via the potentially interrelated pathways of chronic inflammation and cardiovascular risk factors,” Dr. Wu said.
The new study, published in the Journal of Dental Research, is the first to examine the relationships between all three conditions by age group.
Diabetes, edentulism, and cognitive decline
The data came from a total of 9,948 participants in the Health and Retirement Study (HRS) from 2006 to 2018. At baseline, 5,440 participants were aged 65-74 years, 3,300 were aged 75-84, and 1,208 were aged 85 years or older.
They were assessed every 2 years using the 35-point Telephone Survey for Cognitive Status, which included tests of immediate and delayed word recall, repeated subtracting by 7, counting backward from 20, naming objects, and naming the president and vice president of the U.S. As might be expected, the youngest group scored the highest, averaging 23 points, while the oldest group scored lowest, at 18.5 points.
Participants were also asked if they had ever been told by a doctor that they have diabetes. Another question was: “Have you lost all of your upper and lower natural permanent teeth?”
The condition of having no teeth is known as edentulism.
The percentages of participants who reported having both diabetes and edentulism were 6.0%, 6.7%, and 5.0% for those aged 65-74 years, 75-84 years, and 85 years or older, respectively. The proportions with neither of those conditions were 63.5%, 60.4%, and 58.3% in those three age groups, respectively (P < .001).
Compared with their counterparts with neither diabetes nor edentulism at baseline, older adults with both conditions aged 65-74 years (P < .001) and aged 75-84 years had worse cognitive function (P < .001).
In terms of the rate of cognitive decline, compared with those with neither condition from the same age cohort, older adults aged 65-74 years with both conditions declined at a higher rate (P < .001).
Having diabetes alone led to accelerated cognitive decline in older adults aged 65-74 years (P < .001). Having edentulism alone led to accelerated decline in older adults aged 65-74 years (P < .001) and older adults aged 75-84 years (P < 0.01).
“Our study finds the co-occurrence of diabetes and edentulism led to a worse cognitive function and a faster cognitive decline in older adults aged 65-74 years,” say Wu and colleagues.
Study limitations: Better data needed
The study has several limitations, most of them due to the data source. For example, while the HRS collects detailed information on cognitive status, edentulism is its only measure of oral health. There were no data on whether individuals had replacements such as dentures or implants that would affect their ability to eat, which could influence other health factors.
“I have made repeated appeals for federal funding to collect more oral health-related information in large national surveys,” Dr. Wu told this news organization.
Similarly, assessments of diabetes status such as hemoglobin A1c were only available for small subsets and not sufficient to demonstrate statistical significance, she explained.
Dr. Wu suggested that both oral health and cognitive screening might be included in the “Welcome to Medicare” preventive visit. In addition, “Oral hygiene practice should also be highlighted to improve cognitive health. Developing dental care interventions and programs are needed for reducing the societal cost of dementia.”
The study was partially supported by the National Institutes of Health. The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
most specifically in those 65-74 years of age, new findings suggest.
The data come from a 12-year follow-up of older adults in a nationally representative U.S. survey.
“From a clinical perspective, our study demonstrates the importance of improving access to dental health care and integrating primary dental and medical care. Health care professionals and family caregivers should pay close attention to the cognitive status of diabetic older adults with poor oral health status,” lead author Bei Wu, PhD, of New York University, said in an interview. Dr. Wu is the Dean’s Professor in Global Health and codirector of the NYU Aging Incubator.
Moreover, said Dr. Wu: “For individuals with both poor oral health and diabetes, regular dental visits should be encouraged in addition to adherence to the diabetes self-care protocol.”
Diabetes has long been recognized as a risk factor for cognitive decline, but the findings have been inconsistent for different age groups. Tooth loss has also been linked to cognitive decline and dementia, as well as diabetes.
The mechanisms aren’t entirely clear, but “co-occurring diabetes and poor oral health may increase the risk for dementia, possibly via the potentially interrelated pathways of chronic inflammation and cardiovascular risk factors,” Dr. Wu said.
The new study, published in the Journal of Dental Research, is the first to examine the relationships between all three conditions by age group.
Diabetes, edentulism, and cognitive decline
The data came from a total of 9,948 participants in the Health and Retirement Study (HRS) from 2006 to 2018. At baseline, 5,440 participants were aged 65-74 years, 3,300 were aged 75-84, and 1,208 were aged 85 years or older.
They were assessed every 2 years using the 35-point Telephone Survey for Cognitive Status, which included tests of immediate and delayed word recall, repeated subtracting by 7, counting backward from 20, naming objects, and naming the president and vice president of the U.S. As might be expected, the youngest group scored the highest, averaging 23 points, while the oldest group scored lowest, at 18.5 points.
Participants were also asked if they had ever been told by a doctor that they have diabetes. Another question was: “Have you lost all of your upper and lower natural permanent teeth?”
The condition of having no teeth is known as edentulism.
The percentages of participants who reported having both diabetes and edentulism were 6.0%, 6.7%, and 5.0% for those aged 65-74 years, 75-84 years, and 85 years or older, respectively. The proportions with neither of those conditions were 63.5%, 60.4%, and 58.3% in those three age groups, respectively (P < .001).
Compared with their counterparts with neither diabetes nor edentulism at baseline, older adults with both conditions aged 65-74 years (P < .001) and aged 75-84 years had worse cognitive function (P < .001).
In terms of the rate of cognitive decline, compared with those with neither condition from the same age cohort, older adults aged 65-74 years with both conditions declined at a higher rate (P < .001).
Having diabetes alone led to accelerated cognitive decline in older adults aged 65-74 years (P < .001). Having edentulism alone led to accelerated decline in older adults aged 65-74 years (P < .001) and older adults aged 75-84 years (P < 0.01).
“Our study finds the co-occurrence of diabetes and edentulism led to a worse cognitive function and a faster cognitive decline in older adults aged 65-74 years,” say Wu and colleagues.
Study limitations: Better data needed
The study has several limitations, most of them due to the data source. For example, while the HRS collects detailed information on cognitive status, edentulism is its only measure of oral health. There were no data on whether individuals had replacements such as dentures or implants that would affect their ability to eat, which could influence other health factors.
“I have made repeated appeals for federal funding to collect more oral health-related information in large national surveys,” Dr. Wu told this news organization.
Similarly, assessments of diabetes status such as hemoglobin A1c were only available for small subsets and not sufficient to demonstrate statistical significance, she explained.
Dr. Wu suggested that both oral health and cognitive screening might be included in the “Welcome to Medicare” preventive visit. In addition, “Oral hygiene practice should also be highlighted to improve cognitive health. Developing dental care interventions and programs are needed for reducing the societal cost of dementia.”
The study was partially supported by the National Institutes of Health. The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
most specifically in those 65-74 years of age, new findings suggest.
The data come from a 12-year follow-up of older adults in a nationally representative U.S. survey.
“From a clinical perspective, our study demonstrates the importance of improving access to dental health care and integrating primary dental and medical care. Health care professionals and family caregivers should pay close attention to the cognitive status of diabetic older adults with poor oral health status,” lead author Bei Wu, PhD, of New York University, said in an interview. Dr. Wu is the Dean’s Professor in Global Health and codirector of the NYU Aging Incubator.
Moreover, said Dr. Wu: “For individuals with both poor oral health and diabetes, regular dental visits should be encouraged in addition to adherence to the diabetes self-care protocol.”
Diabetes has long been recognized as a risk factor for cognitive decline, but the findings have been inconsistent for different age groups. Tooth loss has also been linked to cognitive decline and dementia, as well as diabetes.
The mechanisms aren’t entirely clear, but “co-occurring diabetes and poor oral health may increase the risk for dementia, possibly via the potentially interrelated pathways of chronic inflammation and cardiovascular risk factors,” Dr. Wu said.
The new study, published in the Journal of Dental Research, is the first to examine the relationships between all three conditions by age group.
Diabetes, edentulism, and cognitive decline
The data came from a total of 9,948 participants in the Health and Retirement Study (HRS) from 2006 to 2018. At baseline, 5,440 participants were aged 65-74 years, 3,300 were aged 75-84, and 1,208 were aged 85 years or older.
They were assessed every 2 years using the 35-point Telephone Survey for Cognitive Status, which included tests of immediate and delayed word recall, repeated subtracting by 7, counting backward from 20, naming objects, and naming the president and vice president of the U.S. As might be expected, the youngest group scored the highest, averaging 23 points, while the oldest group scored lowest, at 18.5 points.
Participants were also asked if they had ever been told by a doctor that they have diabetes. Another question was: “Have you lost all of your upper and lower natural permanent teeth?”
The condition of having no teeth is known as edentulism.
The percentages of participants who reported having both diabetes and edentulism were 6.0%, 6.7%, and 5.0% for those aged 65-74 years, 75-84 years, and 85 years or older, respectively. The proportions with neither of those conditions were 63.5%, 60.4%, and 58.3% in those three age groups, respectively (P < .001).
Compared with their counterparts with neither diabetes nor edentulism at baseline, older adults with both conditions aged 65-74 years (P < .001) and aged 75-84 years had worse cognitive function (P < .001).
In terms of the rate of cognitive decline, compared with those with neither condition from the same age cohort, older adults aged 65-74 years with both conditions declined at a higher rate (P < .001).
Having diabetes alone led to accelerated cognitive decline in older adults aged 65-74 years (P < .001). Having edentulism alone led to accelerated decline in older adults aged 65-74 years (P < .001) and older adults aged 75-84 years (P < 0.01).
“Our study finds the co-occurrence of diabetes and edentulism led to a worse cognitive function and a faster cognitive decline in older adults aged 65-74 years,” say Wu and colleagues.
Study limitations: Better data needed
The study has several limitations, most of them due to the data source. For example, while the HRS collects detailed information on cognitive status, edentulism is its only measure of oral health. There were no data on whether individuals had replacements such as dentures or implants that would affect their ability to eat, which could influence other health factors.
“I have made repeated appeals for federal funding to collect more oral health-related information in large national surveys,” Dr. Wu told this news organization.
Similarly, assessments of diabetes status such as hemoglobin A1c were only available for small subsets and not sufficient to demonstrate statistical significance, she explained.
Dr. Wu suggested that both oral health and cognitive screening might be included in the “Welcome to Medicare” preventive visit. In addition, “Oral hygiene practice should also be highlighted to improve cognitive health. Developing dental care interventions and programs are needed for reducing the societal cost of dementia.”
The study was partially supported by the National Institutes of Health. The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF DENTAL RESEARCH
Holy smoke: Air pollution link to bone damage confirmed
Air pollution appears to contribute independently to bone damage in postmenopausal women, new data suggest.
The findings come from a new analysis of data from the Women’s Health Initiative (WHI) and location-specific air particulate information from the U.S. Environmental Protection Agency.
“Our findings confirm that poor air quality may be a risk factor for bone loss, independent of socioeconomic or demographic factors, and expands previous findings to postmenopausal women. Indeed, to our knowledge, this is the first study of the impact of criteria air pollutants on bone health in postmenopausal women,” Diddier Prada, MD, PhD, Columbia University, New York, and colleagues wrote.
The results are also the first to show that “nitrogen oxides contribute the most to bone damage and that the lumbar spine is one of the most susceptible sites,” they added.
Public health policies should aim to reduce air pollution in general, they wrote, and reducing nitrogen oxides, in particular, will reduce bone damage in postmenopausal women, prevent bone fractures, and reduce the health cost burden associated with osteoporosis in this population.
The findings were recently published in eClinicalMedicine.
Asked to comment, Giovanni Adami, MD, PhD, said in an interview that the study “adds to the body of literature on air pollution and bone health. The study confirms and provides further evidence linking air pollution exposure and osteoporosis.”
Dr. Adami, of the University of Verona (Italy), who also studies this topic, said that these new findings align with those from his group and others.
“The scientific literature in the field is clearly pointing toward a negative effect of chronic pollution exposure on bone health.”
He pointed to one study from his group that found chronic exposure to ultrafine particulate matter is associated with low BMD, and consequently, bone fragility, and another study that showed acute exposure to high levels of pollutants could actually cause fractures.
As for what might be done clinically, Dr. Adami said: “It is difficult to extrapolate direct and immediate recommendations for patients.
“However, it might be acceptable to say that patients at risk of osteoporosis, such as older women or those with prior bone fractures, should avoid chronic exposure to air pollution, perhaps using masks when walking in traffic or using air filters for indoor ventilation.”
Dr. Adami also said that this evidence so far might spur the future inclusion of chronic exposure to air pollution in fracture risk assessment tools, although this isn’t likely to come about in the near future.
Particulates linked to whole-body, hip, lumbar, and femoral neck BMD
The prospective observational study included 9,041 WHI participants seen over 32,663 visits who were an average of 63 years old at baseline. More than 70% were White, and just under half were college graduates.
With geocoded address data used to estimate particulate matter concentrations, mean levels of particulate matter of 10 mcm or less, nitrogen oxide nitrogen dioxide, and sulfur dioxide over 1, 3, and 5 years were all negatively associated with whole-body, total hip, femoral neck, and lumbar spine BMD.
In the multivariate analysis, the highest correlations were found between nitrogen oxide and nitrogen dioxide. For example, lumbar spine BMD decreased by 0.026 g/cm2 per year per 10% increase in 3-year mean nitrogen dioxide concentration.
“Our findings show that both particulate matter and gases may adversely impact BMD and that nitrogen oxides may play a critical role in bone damage and osteoporosis risk,” Dr. Prada and colleagues wrote.
Dr. Adami added: “We need more data to understand the precise magnitude of effect of air pollution on fractures, which might depend on levels of exposure but also on genetics and lifestyle.”
The study was funded by the National Institutes of Health. The authors reported no relevant financial relationships. Dr. Adami reported receiving fees from Amgen, Eli Lilly, UCB, Fresenius Kabi, Galapagos, and Theramex.
A version of this article originally appeared on Medscape.com.
Air pollution appears to contribute independently to bone damage in postmenopausal women, new data suggest.
The findings come from a new analysis of data from the Women’s Health Initiative (WHI) and location-specific air particulate information from the U.S. Environmental Protection Agency.
“Our findings confirm that poor air quality may be a risk factor for bone loss, independent of socioeconomic or demographic factors, and expands previous findings to postmenopausal women. Indeed, to our knowledge, this is the first study of the impact of criteria air pollutants on bone health in postmenopausal women,” Diddier Prada, MD, PhD, Columbia University, New York, and colleagues wrote.
The results are also the first to show that “nitrogen oxides contribute the most to bone damage and that the lumbar spine is one of the most susceptible sites,” they added.
Public health policies should aim to reduce air pollution in general, they wrote, and reducing nitrogen oxides, in particular, will reduce bone damage in postmenopausal women, prevent bone fractures, and reduce the health cost burden associated with osteoporosis in this population.
The findings were recently published in eClinicalMedicine.
Asked to comment, Giovanni Adami, MD, PhD, said in an interview that the study “adds to the body of literature on air pollution and bone health. The study confirms and provides further evidence linking air pollution exposure and osteoporosis.”
Dr. Adami, of the University of Verona (Italy), who also studies this topic, said that these new findings align with those from his group and others.
“The scientific literature in the field is clearly pointing toward a negative effect of chronic pollution exposure on bone health.”
He pointed to one study from his group that found chronic exposure to ultrafine particulate matter is associated with low BMD, and consequently, bone fragility, and another study that showed acute exposure to high levels of pollutants could actually cause fractures.
As for what might be done clinically, Dr. Adami said: “It is difficult to extrapolate direct and immediate recommendations for patients.
“However, it might be acceptable to say that patients at risk of osteoporosis, such as older women or those with prior bone fractures, should avoid chronic exposure to air pollution, perhaps using masks when walking in traffic or using air filters for indoor ventilation.”
Dr. Adami also said that this evidence so far might spur the future inclusion of chronic exposure to air pollution in fracture risk assessment tools, although this isn’t likely to come about in the near future.
Particulates linked to whole-body, hip, lumbar, and femoral neck BMD
The prospective observational study included 9,041 WHI participants seen over 32,663 visits who were an average of 63 years old at baseline. More than 70% were White, and just under half were college graduates.
With geocoded address data used to estimate particulate matter concentrations, mean levels of particulate matter of 10 mcm or less, nitrogen oxide nitrogen dioxide, and sulfur dioxide over 1, 3, and 5 years were all negatively associated with whole-body, total hip, femoral neck, and lumbar spine BMD.
In the multivariate analysis, the highest correlations were found between nitrogen oxide and nitrogen dioxide. For example, lumbar spine BMD decreased by 0.026 g/cm2 per year per 10% increase in 3-year mean nitrogen dioxide concentration.
“Our findings show that both particulate matter and gases may adversely impact BMD and that nitrogen oxides may play a critical role in bone damage and osteoporosis risk,” Dr. Prada and colleagues wrote.
Dr. Adami added: “We need more data to understand the precise magnitude of effect of air pollution on fractures, which might depend on levels of exposure but also on genetics and lifestyle.”
The study was funded by the National Institutes of Health. The authors reported no relevant financial relationships. Dr. Adami reported receiving fees from Amgen, Eli Lilly, UCB, Fresenius Kabi, Galapagos, and Theramex.
A version of this article originally appeared on Medscape.com.
Air pollution appears to contribute independently to bone damage in postmenopausal women, new data suggest.
The findings come from a new analysis of data from the Women’s Health Initiative (WHI) and location-specific air particulate information from the U.S. Environmental Protection Agency.
“Our findings confirm that poor air quality may be a risk factor for bone loss, independent of socioeconomic or demographic factors, and expands previous findings to postmenopausal women. Indeed, to our knowledge, this is the first study of the impact of criteria air pollutants on bone health in postmenopausal women,” Diddier Prada, MD, PhD, Columbia University, New York, and colleagues wrote.
The results are also the first to show that “nitrogen oxides contribute the most to bone damage and that the lumbar spine is one of the most susceptible sites,” they added.
Public health policies should aim to reduce air pollution in general, they wrote, and reducing nitrogen oxides, in particular, will reduce bone damage in postmenopausal women, prevent bone fractures, and reduce the health cost burden associated with osteoporosis in this population.
The findings were recently published in eClinicalMedicine.
Asked to comment, Giovanni Adami, MD, PhD, said in an interview that the study “adds to the body of literature on air pollution and bone health. The study confirms and provides further evidence linking air pollution exposure and osteoporosis.”
Dr. Adami, of the University of Verona (Italy), who also studies this topic, said that these new findings align with those from his group and others.
“The scientific literature in the field is clearly pointing toward a negative effect of chronic pollution exposure on bone health.”
He pointed to one study from his group that found chronic exposure to ultrafine particulate matter is associated with low BMD, and consequently, bone fragility, and another study that showed acute exposure to high levels of pollutants could actually cause fractures.
As for what might be done clinically, Dr. Adami said: “It is difficult to extrapolate direct and immediate recommendations for patients.
“However, it might be acceptable to say that patients at risk of osteoporosis, such as older women or those with prior bone fractures, should avoid chronic exposure to air pollution, perhaps using masks when walking in traffic or using air filters for indoor ventilation.”
Dr. Adami also said that this evidence so far might spur the future inclusion of chronic exposure to air pollution in fracture risk assessment tools, although this isn’t likely to come about in the near future.
Particulates linked to whole-body, hip, lumbar, and femoral neck BMD
The prospective observational study included 9,041 WHI participants seen over 32,663 visits who were an average of 63 years old at baseline. More than 70% were White, and just under half were college graduates.
With geocoded address data used to estimate particulate matter concentrations, mean levels of particulate matter of 10 mcm or less, nitrogen oxide nitrogen dioxide, and sulfur dioxide over 1, 3, and 5 years were all negatively associated with whole-body, total hip, femoral neck, and lumbar spine BMD.
In the multivariate analysis, the highest correlations were found between nitrogen oxide and nitrogen dioxide. For example, lumbar spine BMD decreased by 0.026 g/cm2 per year per 10% increase in 3-year mean nitrogen dioxide concentration.
“Our findings show that both particulate matter and gases may adversely impact BMD and that nitrogen oxides may play a critical role in bone damage and osteoporosis risk,” Dr. Prada and colleagues wrote.
Dr. Adami added: “We need more data to understand the precise magnitude of effect of air pollution on fractures, which might depend on levels of exposure but also on genetics and lifestyle.”
The study was funded by the National Institutes of Health. The authors reported no relevant financial relationships. Dr. Adami reported receiving fees from Amgen, Eli Lilly, UCB, Fresenius Kabi, Galapagos, and Theramex.
A version of this article originally appeared on Medscape.com.
FROM ECLINICALMEDICINE
Artificial pancreas ‘superior’ in young kids with type 1 diabetes
A hybrid closed-loop automated insulin delivery system improved time-in-range for blood glucose, compared with standard care, for children with type 1 diabetes in a 13-week trial.
The hybrid closed-loop system, also called automated insulin delivery or artificial pancreas, was composed of a t:slim X2 insulin pump, a Dexcom G6 continuous glucose monitor (CGM), and Control-IQ technology system algorithm software (Tandem Diabetes Care). The system was approved in the United States in 2018 for adults and children as young as 6 years.
Type 1 diabetes treatment is particularly challenging in children younger than 6 because of their small insulin dosing requirements and unpredictable eating and activity habits, lead author R. Paul Wadwa, MD, of the Barbara Davis Center for Diabetes, University of Colorado at Denver, Aurora, and colleagues wrote.
Thus far in the United States, only the Medtronic MiniMed 770G and the Omnipod 5 automated insulin delivery systems are approved for children as young as 2 years, they noted.
In the current study of 102 children with type 1 diabetes aged at least 2 years but younger than 6 years, time-in-range over 13 weeks was higher for those randomized to the hybrid closed-loop system, compared with standard of care; the latter included either an insulin pump or multiple daily injections plus a separate Dexcom G6 CGM.
The hybrid closed-loop system added an average of about 3 hours in ideal blood glucose range over the 13 weeks, compared with no change with standard care.
Moreover, the trial was conducted during the COVID-19 pandemic, necessitating virtual care for most of the study participants. As a result, more than 80% of the training on use of the system and over 90% of all the visits were conducted virtually.
“Successful use of the closed-loop system under these conditions is an important finding that could affect the approach to initiating and monitoring the use of the closed-loop system and expand the use of such systems, particularly in patients living in areas without an endocrinologist but with reliable internet access,” the investigators wrote.
Their findings were published online in the New England Journal of Medicine.
“These results suggest that, in very young children, closed-loop systems are superior to standard care with respect to glucose control,” Daniela Bruttomesso, MD, PhD, of the University of Padua (Italy) wrote in an accompanying editorial.
“Moreover, they show that the closed-loop system can be started remotely in children in this age range, with results that are similar to those obtained when parents or guardians receive face-to-face education about the use of these systems. The closed-loop system used in this trial appeared to be safe and effective.”
Dr. Bruttomesso added: “Although the results were solid, the trial period was only 13 weeks, and there were more unscheduled contacts in the closed-loop group than in the standard care group. In addition, the authors compared a closed-loop system with standard care, rather than in-person initiation of a closed-loop system with remote initiation.”
More time-in-range, no hypoglycemia with automated system
The 102 children were enrolled in the trial between April 28, 2021, and Jan. 13, 2022, at three different U.S. study sites; 68 children were randomized to the closed-loop system and 34 children to standard care. All but one participant completed the 13-week study.
Both groups had virtual or in-person trial visits at 2, 6, and 13 weeks after randomization, and telephone contact at 1 and 10 weeks. Training was virtual for 55 of the 68 children in the closed-loop group (81%). A total of 91% of 407 study visits in the closed-loop and 96% of 204 study visits in the standard-care group were also virtual.
The mean percentage of time spent in target glucose range (70-180 mg/dL) increased from 56.9% at baseline to 69.3% at 13 weeks for the closed-loop group, compared with virtually no change, from 54.9% to 55.9%, in the standard-care group. The mean adjusted difference between the two groups was significant (P < .001).
The closed-loop group also spent significantly less time than the standard-care group with glucose levels above 250 mg/dL during the study period (8.4% vs. 15.0%; P < .001), had lower mean glucose levels (155 vs. 174 mg/dL; P < .001), and lower hemoglobin A1c (7.0% vs. 7.5%; P < .001).
However, time spent with glucose levels below 70 mg/dL (3.0% vs. 3.0%; P = .57) and below 54 mg/dL (0.6% vs. 0.5%) didn’t differ between the groups.
There were two cases of severe hypoglycemia in the closed-loop group and one in the standard-care group. One case of diabetic ketoacidosis related to infusion set failure occurred in the closed-loop group versus none in the standard-care group.
Dr. Bruttomesso commented that a virtual approach has several advantages over in-person visits, including “a more relaxed environment, lower travel costs, and greater ease of contact with clinicians.”
At the same time, though, “patient preferences, possible legal issues, and accessibility to technology ... are all important considerations in choosing the most appropriate way to communicate with patients at the initiation of a closed-loop system or during routine follow-up.” The families of the patients in this trial had above-average incomes, she pointed out.
Ultimately, she said, “A mix of face-to-face visits and virtual clinic meetings may become routine in the management of diabetes in young children.”
The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Wadwa reported receiving grants/contracts from Beta Bionics, Dexcom, Eli Lilly, and MannKind, travel fees from Eli Lilly, and lecture fees from Tandem Diabetes Care, and serves as a consultant for Dexcom. Dr. Bruttomesso reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A hybrid closed-loop automated insulin delivery system improved time-in-range for blood glucose, compared with standard care, for children with type 1 diabetes in a 13-week trial.
The hybrid closed-loop system, also called automated insulin delivery or artificial pancreas, was composed of a t:slim X2 insulin pump, a Dexcom G6 continuous glucose monitor (CGM), and Control-IQ technology system algorithm software (Tandem Diabetes Care). The system was approved in the United States in 2018 for adults and children as young as 6 years.
Type 1 diabetes treatment is particularly challenging in children younger than 6 because of their small insulin dosing requirements and unpredictable eating and activity habits, lead author R. Paul Wadwa, MD, of the Barbara Davis Center for Diabetes, University of Colorado at Denver, Aurora, and colleagues wrote.
Thus far in the United States, only the Medtronic MiniMed 770G and the Omnipod 5 automated insulin delivery systems are approved for children as young as 2 years, they noted.
In the current study of 102 children with type 1 diabetes aged at least 2 years but younger than 6 years, time-in-range over 13 weeks was higher for those randomized to the hybrid closed-loop system, compared with standard of care; the latter included either an insulin pump or multiple daily injections plus a separate Dexcom G6 CGM.
The hybrid closed-loop system added an average of about 3 hours in ideal blood glucose range over the 13 weeks, compared with no change with standard care.
Moreover, the trial was conducted during the COVID-19 pandemic, necessitating virtual care for most of the study participants. As a result, more than 80% of the training on use of the system and over 90% of all the visits were conducted virtually.
“Successful use of the closed-loop system under these conditions is an important finding that could affect the approach to initiating and monitoring the use of the closed-loop system and expand the use of such systems, particularly in patients living in areas without an endocrinologist but with reliable internet access,” the investigators wrote.
Their findings were published online in the New England Journal of Medicine.
“These results suggest that, in very young children, closed-loop systems are superior to standard care with respect to glucose control,” Daniela Bruttomesso, MD, PhD, of the University of Padua (Italy) wrote in an accompanying editorial.
“Moreover, they show that the closed-loop system can be started remotely in children in this age range, with results that are similar to those obtained when parents or guardians receive face-to-face education about the use of these systems. The closed-loop system used in this trial appeared to be safe and effective.”
Dr. Bruttomesso added: “Although the results were solid, the trial period was only 13 weeks, and there were more unscheduled contacts in the closed-loop group than in the standard care group. In addition, the authors compared a closed-loop system with standard care, rather than in-person initiation of a closed-loop system with remote initiation.”
More time-in-range, no hypoglycemia with automated system
The 102 children were enrolled in the trial between April 28, 2021, and Jan. 13, 2022, at three different U.S. study sites; 68 children were randomized to the closed-loop system and 34 children to standard care. All but one participant completed the 13-week study.
Both groups had virtual or in-person trial visits at 2, 6, and 13 weeks after randomization, and telephone contact at 1 and 10 weeks. Training was virtual for 55 of the 68 children in the closed-loop group (81%). A total of 91% of 407 study visits in the closed-loop and 96% of 204 study visits in the standard-care group were also virtual.
The mean percentage of time spent in target glucose range (70-180 mg/dL) increased from 56.9% at baseline to 69.3% at 13 weeks for the closed-loop group, compared with virtually no change, from 54.9% to 55.9%, in the standard-care group. The mean adjusted difference between the two groups was significant (P < .001).
The closed-loop group also spent significantly less time than the standard-care group with glucose levels above 250 mg/dL during the study period (8.4% vs. 15.0%; P < .001), had lower mean glucose levels (155 vs. 174 mg/dL; P < .001), and lower hemoglobin A1c (7.0% vs. 7.5%; P < .001).
However, time spent with glucose levels below 70 mg/dL (3.0% vs. 3.0%; P = .57) and below 54 mg/dL (0.6% vs. 0.5%) didn’t differ between the groups.
There were two cases of severe hypoglycemia in the closed-loop group and one in the standard-care group. One case of diabetic ketoacidosis related to infusion set failure occurred in the closed-loop group versus none in the standard-care group.
Dr. Bruttomesso commented that a virtual approach has several advantages over in-person visits, including “a more relaxed environment, lower travel costs, and greater ease of contact with clinicians.”
At the same time, though, “patient preferences, possible legal issues, and accessibility to technology ... are all important considerations in choosing the most appropriate way to communicate with patients at the initiation of a closed-loop system or during routine follow-up.” The families of the patients in this trial had above-average incomes, she pointed out.
Ultimately, she said, “A mix of face-to-face visits and virtual clinic meetings may become routine in the management of diabetes in young children.”
The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Wadwa reported receiving grants/contracts from Beta Bionics, Dexcom, Eli Lilly, and MannKind, travel fees from Eli Lilly, and lecture fees from Tandem Diabetes Care, and serves as a consultant for Dexcom. Dr. Bruttomesso reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A hybrid closed-loop automated insulin delivery system improved time-in-range for blood glucose, compared with standard care, for children with type 1 diabetes in a 13-week trial.
The hybrid closed-loop system, also called automated insulin delivery or artificial pancreas, was composed of a t:slim X2 insulin pump, a Dexcom G6 continuous glucose monitor (CGM), and Control-IQ technology system algorithm software (Tandem Diabetes Care). The system was approved in the United States in 2018 for adults and children as young as 6 years.
Type 1 diabetes treatment is particularly challenging in children younger than 6 because of their small insulin dosing requirements and unpredictable eating and activity habits, lead author R. Paul Wadwa, MD, of the Barbara Davis Center for Diabetes, University of Colorado at Denver, Aurora, and colleagues wrote.
Thus far in the United States, only the Medtronic MiniMed 770G and the Omnipod 5 automated insulin delivery systems are approved for children as young as 2 years, they noted.
In the current study of 102 children with type 1 diabetes aged at least 2 years but younger than 6 years, time-in-range over 13 weeks was higher for those randomized to the hybrid closed-loop system, compared with standard of care; the latter included either an insulin pump or multiple daily injections plus a separate Dexcom G6 CGM.
The hybrid closed-loop system added an average of about 3 hours in ideal blood glucose range over the 13 weeks, compared with no change with standard care.
Moreover, the trial was conducted during the COVID-19 pandemic, necessitating virtual care for most of the study participants. As a result, more than 80% of the training on use of the system and over 90% of all the visits were conducted virtually.
“Successful use of the closed-loop system under these conditions is an important finding that could affect the approach to initiating and monitoring the use of the closed-loop system and expand the use of such systems, particularly in patients living in areas without an endocrinologist but with reliable internet access,” the investigators wrote.
Their findings were published online in the New England Journal of Medicine.
“These results suggest that, in very young children, closed-loop systems are superior to standard care with respect to glucose control,” Daniela Bruttomesso, MD, PhD, of the University of Padua (Italy) wrote in an accompanying editorial.
“Moreover, they show that the closed-loop system can be started remotely in children in this age range, with results that are similar to those obtained when parents or guardians receive face-to-face education about the use of these systems. The closed-loop system used in this trial appeared to be safe and effective.”
Dr. Bruttomesso added: “Although the results were solid, the trial period was only 13 weeks, and there were more unscheduled contacts in the closed-loop group than in the standard care group. In addition, the authors compared a closed-loop system with standard care, rather than in-person initiation of a closed-loop system with remote initiation.”
More time-in-range, no hypoglycemia with automated system
The 102 children were enrolled in the trial between April 28, 2021, and Jan. 13, 2022, at three different U.S. study sites; 68 children were randomized to the closed-loop system and 34 children to standard care. All but one participant completed the 13-week study.
Both groups had virtual or in-person trial visits at 2, 6, and 13 weeks after randomization, and telephone contact at 1 and 10 weeks. Training was virtual for 55 of the 68 children in the closed-loop group (81%). A total of 91% of 407 study visits in the closed-loop and 96% of 204 study visits in the standard-care group were also virtual.
The mean percentage of time spent in target glucose range (70-180 mg/dL) increased from 56.9% at baseline to 69.3% at 13 weeks for the closed-loop group, compared with virtually no change, from 54.9% to 55.9%, in the standard-care group. The mean adjusted difference between the two groups was significant (P < .001).
The closed-loop group also spent significantly less time than the standard-care group with glucose levels above 250 mg/dL during the study period (8.4% vs. 15.0%; P < .001), had lower mean glucose levels (155 vs. 174 mg/dL; P < .001), and lower hemoglobin A1c (7.0% vs. 7.5%; P < .001).
However, time spent with glucose levels below 70 mg/dL (3.0% vs. 3.0%; P = .57) and below 54 mg/dL (0.6% vs. 0.5%) didn’t differ between the groups.
There were two cases of severe hypoglycemia in the closed-loop group and one in the standard-care group. One case of diabetic ketoacidosis related to infusion set failure occurred in the closed-loop group versus none in the standard-care group.
Dr. Bruttomesso commented that a virtual approach has several advantages over in-person visits, including “a more relaxed environment, lower travel costs, and greater ease of contact with clinicians.”
At the same time, though, “patient preferences, possible legal issues, and accessibility to technology ... are all important considerations in choosing the most appropriate way to communicate with patients at the initiation of a closed-loop system or during routine follow-up.” The families of the patients in this trial had above-average incomes, she pointed out.
Ultimately, she said, “A mix of face-to-face visits and virtual clinic meetings may become routine in the management of diabetes in young children.”
The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Wadwa reported receiving grants/contracts from Beta Bionics, Dexcom, Eli Lilly, and MannKind, travel fees from Eli Lilly, and lecture fees from Tandem Diabetes Care, and serves as a consultant for Dexcom. Dr. Bruttomesso reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
High caffeine levels may lower body fat, type 2 diabetes risks
the results of a new study suggest.
Explaining that caffeine has thermogenic effects, the researchers note that previous short-term studies have linked caffeine intake with reductions in weight and fat mass. And observational data have shown associations between coffee consumption and lower risks of type 2 diabetes and cardiovascular disease.
In an effort to isolate the effects of caffeine from those of other food and drink components, Susanna C. Larsson, PhD, of the Karolinska Institute, Stockholm, and colleagues used data from studies of mainly European populations to examine two specific genetic mutations that have been linked to a slower speed of caffeine metabolism.
The two gene variants resulted in “genetically predicted, lifelong, higher plasma caffeine concentrations,” the researchers note “and were associated with lower body mass index and fat mass, as well as a lower risk of type 2 diabetes.”
Approximately half of the effect of caffeine on type 2 diabetes was estimated to be mediated through body mass index (BMI) reduction.
The work was published online March 14 in BMJ Medicine.
“This publication supports existing studies suggesting a link between caffeine consumption and increased fat burn,” notes Stephen Lawrence, MBChB, Warwick (England) University. “The big leap of faith that the authors have made is to assume that the weight loss brought about by increased caffeine consumption is sufficient to reduce the risk of developing type 2 diabetes,” he told the UK Science Media Centre.
“It does not, however, prove cause and effect.”
The researchers agree, noting: “Further clinical study is warranted to investigate the translational potential of these findings towards reducing the burden of metabolic disease.”
Katarina Kos, MD, PhD, a senior lecturer in diabetes and obesity at the University of Exeter (England), emphasized that this genetic study “shows links and potential health benefits for people with certain genes attributed to a faster [caffeine] metabolism as a hereditary trait and potentially a better metabolism.”
“It does not study or recommend drinking more coffee, which was not the purpose of this research,” she told the UK Science Media Centre.
Using Mendelian randomization, Dr. Larsson and colleagues examined data that came from a genomewide association meta-analysis of 9,876 individuals of European ancestry from six population-based studies.
Genetically predicted higher plasma caffeine concentrations in those carrying the two gene variants were associated with a lower BMI, with one standard deviation increase in predicted plasma caffeine equaling about 4.8 kg/m2 in BMI (P < .001).
For whole-body fat mass, one standard deviation increase in plasma caffeine equaled a reduction of about 9.5 kg (P < .001). However, there was no significant association with fat-free body mass (P = .17).
Genetically predicted higher plasma caffeine concentrations were also associated with a lower risk for type 2 diabetes in the FinnGen study (odds ratio, 0.77 per standard deviation increase; P < .001) and the DIAMANTE consortia (0.84, P < .001).
Combined, the odds ratio of type 2 diabetes per standard deviation of plasma caffeine increase was 0.81 (P < .001).
Dr. Larsson and colleagues calculated that approximately 43% of the protective effect of plasma caffeine on type 2 diabetes was mediated through BMI.
They did not find any strong associations between genetically predicted plasma caffeine concentrations and risk of any of the studied cardiovascular disease outcomes (ischemic heart disease, atrial fibrillation, heart failure, and stroke).
The thermogenic response to caffeine has been previously quantified as an approximate 100 kcal increase in energy expenditure per 100 mg daily caffeine intake, an amount that could result in reduced obesity risk. Another possible mechanism is enhanced satiety and suppressed energy intake with higher caffeine levels, the researchers say.
“Long-term clinical studies investigating the effect of caffeine intake on fat mass and type 2 diabetes risk are warranted,” they note. “Randomized controlled trials are warranted to assess whether noncaloric caffeine-containing beverages might play a role in reducing the risk of obesity and type 2 diabetes.”
The study was supported by the Swedish Research Council for Health, Working Life and Welfare, Swedish Heart Lung Foundation, and Swedish Research Council. Dr. Larsson, Dr. Lawrence, and Dr. Kos have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
the results of a new study suggest.
Explaining that caffeine has thermogenic effects, the researchers note that previous short-term studies have linked caffeine intake with reductions in weight and fat mass. And observational data have shown associations between coffee consumption and lower risks of type 2 diabetes and cardiovascular disease.
In an effort to isolate the effects of caffeine from those of other food and drink components, Susanna C. Larsson, PhD, of the Karolinska Institute, Stockholm, and colleagues used data from studies of mainly European populations to examine two specific genetic mutations that have been linked to a slower speed of caffeine metabolism.
The two gene variants resulted in “genetically predicted, lifelong, higher plasma caffeine concentrations,” the researchers note “and were associated with lower body mass index and fat mass, as well as a lower risk of type 2 diabetes.”
Approximately half of the effect of caffeine on type 2 diabetes was estimated to be mediated through body mass index (BMI) reduction.
The work was published online March 14 in BMJ Medicine.
“This publication supports existing studies suggesting a link between caffeine consumption and increased fat burn,” notes Stephen Lawrence, MBChB, Warwick (England) University. “The big leap of faith that the authors have made is to assume that the weight loss brought about by increased caffeine consumption is sufficient to reduce the risk of developing type 2 diabetes,” he told the UK Science Media Centre.
“It does not, however, prove cause and effect.”
The researchers agree, noting: “Further clinical study is warranted to investigate the translational potential of these findings towards reducing the burden of metabolic disease.”
Katarina Kos, MD, PhD, a senior lecturer in diabetes and obesity at the University of Exeter (England), emphasized that this genetic study “shows links and potential health benefits for people with certain genes attributed to a faster [caffeine] metabolism as a hereditary trait and potentially a better metabolism.”
“It does not study or recommend drinking more coffee, which was not the purpose of this research,” she told the UK Science Media Centre.
Using Mendelian randomization, Dr. Larsson and colleagues examined data that came from a genomewide association meta-analysis of 9,876 individuals of European ancestry from six population-based studies.
Genetically predicted higher plasma caffeine concentrations in those carrying the two gene variants were associated with a lower BMI, with one standard deviation increase in predicted plasma caffeine equaling about 4.8 kg/m2 in BMI (P < .001).
For whole-body fat mass, one standard deviation increase in plasma caffeine equaled a reduction of about 9.5 kg (P < .001). However, there was no significant association with fat-free body mass (P = .17).
Genetically predicted higher plasma caffeine concentrations were also associated with a lower risk for type 2 diabetes in the FinnGen study (odds ratio, 0.77 per standard deviation increase; P < .001) and the DIAMANTE consortia (0.84, P < .001).
Combined, the odds ratio of type 2 diabetes per standard deviation of plasma caffeine increase was 0.81 (P < .001).
Dr. Larsson and colleagues calculated that approximately 43% of the protective effect of plasma caffeine on type 2 diabetes was mediated through BMI.
They did not find any strong associations between genetically predicted plasma caffeine concentrations and risk of any of the studied cardiovascular disease outcomes (ischemic heart disease, atrial fibrillation, heart failure, and stroke).
The thermogenic response to caffeine has been previously quantified as an approximate 100 kcal increase in energy expenditure per 100 mg daily caffeine intake, an amount that could result in reduced obesity risk. Another possible mechanism is enhanced satiety and suppressed energy intake with higher caffeine levels, the researchers say.
“Long-term clinical studies investigating the effect of caffeine intake on fat mass and type 2 diabetes risk are warranted,” they note. “Randomized controlled trials are warranted to assess whether noncaloric caffeine-containing beverages might play a role in reducing the risk of obesity and type 2 diabetes.”
The study was supported by the Swedish Research Council for Health, Working Life and Welfare, Swedish Heart Lung Foundation, and Swedish Research Council. Dr. Larsson, Dr. Lawrence, and Dr. Kos have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
the results of a new study suggest.
Explaining that caffeine has thermogenic effects, the researchers note that previous short-term studies have linked caffeine intake with reductions in weight and fat mass. And observational data have shown associations between coffee consumption and lower risks of type 2 diabetes and cardiovascular disease.
In an effort to isolate the effects of caffeine from those of other food and drink components, Susanna C. Larsson, PhD, of the Karolinska Institute, Stockholm, and colleagues used data from studies of mainly European populations to examine two specific genetic mutations that have been linked to a slower speed of caffeine metabolism.
The two gene variants resulted in “genetically predicted, lifelong, higher plasma caffeine concentrations,” the researchers note “and were associated with lower body mass index and fat mass, as well as a lower risk of type 2 diabetes.”
Approximately half of the effect of caffeine on type 2 diabetes was estimated to be mediated through body mass index (BMI) reduction.
The work was published online March 14 in BMJ Medicine.
“This publication supports existing studies suggesting a link between caffeine consumption and increased fat burn,” notes Stephen Lawrence, MBChB, Warwick (England) University. “The big leap of faith that the authors have made is to assume that the weight loss brought about by increased caffeine consumption is sufficient to reduce the risk of developing type 2 diabetes,” he told the UK Science Media Centre.
“It does not, however, prove cause and effect.”
The researchers agree, noting: “Further clinical study is warranted to investigate the translational potential of these findings towards reducing the burden of metabolic disease.”
Katarina Kos, MD, PhD, a senior lecturer in diabetes and obesity at the University of Exeter (England), emphasized that this genetic study “shows links and potential health benefits for people with certain genes attributed to a faster [caffeine] metabolism as a hereditary trait and potentially a better metabolism.”
“It does not study or recommend drinking more coffee, which was not the purpose of this research,” she told the UK Science Media Centre.
Using Mendelian randomization, Dr. Larsson and colleagues examined data that came from a genomewide association meta-analysis of 9,876 individuals of European ancestry from six population-based studies.
Genetically predicted higher plasma caffeine concentrations in those carrying the two gene variants were associated with a lower BMI, with one standard deviation increase in predicted plasma caffeine equaling about 4.8 kg/m2 in BMI (P < .001).
For whole-body fat mass, one standard deviation increase in plasma caffeine equaled a reduction of about 9.5 kg (P < .001). However, there was no significant association with fat-free body mass (P = .17).
Genetically predicted higher plasma caffeine concentrations were also associated with a lower risk for type 2 diabetes in the FinnGen study (odds ratio, 0.77 per standard deviation increase; P < .001) and the DIAMANTE consortia (0.84, P < .001).
Combined, the odds ratio of type 2 diabetes per standard deviation of plasma caffeine increase was 0.81 (P < .001).
Dr. Larsson and colleagues calculated that approximately 43% of the protective effect of plasma caffeine on type 2 diabetes was mediated through BMI.
They did not find any strong associations between genetically predicted plasma caffeine concentrations and risk of any of the studied cardiovascular disease outcomes (ischemic heart disease, atrial fibrillation, heart failure, and stroke).
The thermogenic response to caffeine has been previously quantified as an approximate 100 kcal increase in energy expenditure per 100 mg daily caffeine intake, an amount that could result in reduced obesity risk. Another possible mechanism is enhanced satiety and suppressed energy intake with higher caffeine levels, the researchers say.
“Long-term clinical studies investigating the effect of caffeine intake on fat mass and type 2 diabetes risk are warranted,” they note. “Randomized controlled trials are warranted to assess whether noncaloric caffeine-containing beverages might play a role in reducing the risk of obesity and type 2 diabetes.”
The study was supported by the Swedish Research Council for Health, Working Life and Welfare, Swedish Heart Lung Foundation, and Swedish Research Council. Dr. Larsson, Dr. Lawrence, and Dr. Kos have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM BMJ MEDICINE