Manasi Talwadekar

TOPLINE:

Moderate to vigorous aerobic physical activity performed in the evening is associated with the lowest risk for mortality, cardiovascular disease (CVD), and microvascular disease (MVD) in adults with obesity, including those with type 2 diabetes (T2D).

METHODOLOGY:

• Bouts of moderate to vigorous aerobic physical activity are widely recognized to improve cardiometabolic risk factors, but whether morning, afternoon, or evening timing may lead to greater improvements is unclear.
• Researchers analyzed UK Biobank data of 29,836 participants with obesity (body mass index, › 30; mean age, 62.2 years; 53.2% women), including 2995 also diagnosed with T2D, all enrolled in 2006-2010.
• Aerobic activity was defined as bouts lasting ≥ 3 minutes, and the intensity of activity was classified as light, moderate, or vigorous using accelerometer data collected from participants.
• Participants were stratified into the morning (6 a.m. to < 12 p.m.), afternoon (12 p.m. to < 6 p.m.), and evening (6 p.m. to < 12 a.m.) groups based on when > 50% of their total moderate to vigorous activity occurred, and those with no aerobic bouts were considered the reference group.
• The association between the timing of aerobic physical activity and risk for all-cause mortality, CVD (defined as circulatory, such as hypertension), and MVD (neuropathy, nephropathy, or retinopathy) was evaluated over a median follow-up of 7.9 years.

TAKEAWAY:

• Mortality risk was lowest in the evening moderate to vigorous physical activity group (hazard ratio [HR], 0.39; 95% CI, 0.27-0.55) and even lower in the T2D subgroup (HR, 0.24; 95% CI, 0.08-0.76) than in the reference group.
• Mortality risk was lower in the afternoon (HR, 0.60; 95% CI, 0.51-0.71) and morning (HR, 0.67; 95% CI, 0.56-0.79) activity groups than in the reference group, but this association was weaker than that observed in the evening activity group.
• The evening moderate to vigorous activity group had a lower risk for CVD (HR, 0.64; 95% CI, 0.54-0.75) and MVD (HR, 0.76; 95% CI, 0.63-0.92) than the reference group.
• Among participants with obesity and T2D, moderate to vigorous physical activity in the evening was associated with a lower risk for mortality, CVD, and MVD.

IN PRACTICE:

The authors wrote, “The results of this study emphasize that beyond the total volume of MVPA [moderate to vigorous physical activity], its timing, particularly in the evening, was consistently associated with the lowest risk of mortality relative to other timing windows.”

SOURCE:

The study, led by Angelo Sabag, PhD, Charles Perkins Centre, University of Sydney, Australia, was published online in Diabetes Care.

LIMITATIONS:

Because this was an observational study, the possibility of reverse causation from prodromal disease and unaccounted confounding factors could not have been ruled out. There was a lag of a median of 5.5 years between the UK Biobank baseline, when covariate measurements were taken, and the accelerometry study. Moreover, the response rate of the UK Biobank was low.

DISCLOSURES:

The study was funded by an Australian National Health and Medical Research Council Investigator Grant and the National Heart Foundation of Australia Postdoctoral Fellowship. The authors reported no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Moderate to vigorous aerobic physical activity performed in the evening is associated with the lowest risk for mortality, cardiovascular disease (CVD), and microvascular disease (MVD) in adults with obesity, including those with type 2 diabetes (T2D).

METHODOLOGY:

• Bouts of moderate to vigorous aerobic physical activity are widely recognized to improve cardiometabolic risk factors, but whether morning, afternoon, or evening timing may lead to greater improvements is unclear.
• Researchers analyzed UK Biobank data of 29,836 participants with obesity (body mass index, › 30; mean age, 62.2 years; 53.2% women), including 2995 also diagnosed with T2D, all enrolled in 2006-2010.
• Aerobic activity was defined as bouts lasting ≥ 3 minutes, and the intensity of activity was classified as light, moderate, or vigorous using accelerometer data collected from participants.
• Participants were stratified into the morning (6 a.m. to < 12 p.m.), afternoon (12 p.m. to < 6 p.m.), and evening (6 p.m. to < 12 a.m.) groups based on when > 50% of their total moderate to vigorous activity occurred, and those with no aerobic bouts were considered the reference group.
• The association between the timing of aerobic physical activity and risk for all-cause mortality, CVD (defined as circulatory, such as hypertension), and MVD (neuropathy, nephropathy, or retinopathy) was evaluated over a median follow-up of 7.9 years.

TAKEAWAY:

• Mortality risk was lowest in the evening moderate to vigorous physical activity group (hazard ratio [HR], 0.39; 95% CI, 0.27-0.55) and even lower in the T2D subgroup (HR, 0.24; 95% CI, 0.08-0.76) than in the reference group.
• Mortality risk was lower in the afternoon (HR, 0.60; 95% CI, 0.51-0.71) and morning (HR, 0.67; 95% CI, 0.56-0.79) activity groups than in the reference group, but this association was weaker than that observed in the evening activity group.
• The evening moderate to vigorous activity group had a lower risk for CVD (HR, 0.64; 95% CI, 0.54-0.75) and MVD (HR, 0.76; 95% CI, 0.63-0.92) than the reference group.
• Among participants with obesity and T2D, moderate to vigorous physical activity in the evening was associated with a lower risk for mortality, CVD, and MVD.

IN PRACTICE:

The authors wrote, “The results of this study emphasize that beyond the total volume of MVPA [moderate to vigorous physical activity], its timing, particularly in the evening, was consistently associated with the lowest risk of mortality relative to other timing windows.”

SOURCE:

The study, led by Angelo Sabag, PhD, Charles Perkins Centre, University of Sydney, Australia, was published online in Diabetes Care.

LIMITATIONS:

Because this was an observational study, the possibility of reverse causation from prodromal disease and unaccounted confounding factors could not have been ruled out. There was a lag of a median of 5.5 years between the UK Biobank baseline, when covariate measurements were taken, and the accelerometry study. Moreover, the response rate of the UK Biobank was low.

DISCLOSURES:

The study was funded by an Australian National Health and Medical Research Council Investigator Grant and the National Heart Foundation of Australia Postdoctoral Fellowship. The authors reported no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Moderate to vigorous aerobic physical activity performed in the evening is associated with the lowest risk for mortality, cardiovascular disease (CVD), and microvascular disease (MVD) in adults with obesity, including those with type 2 diabetes (T2D).

METHODOLOGY:

• Bouts of moderate to vigorous aerobic physical activity are widely recognized to improve cardiometabolic risk factors, but whether morning, afternoon, or evening timing may lead to greater improvements is unclear.
• Researchers analyzed UK Biobank data of 29,836 participants with obesity (body mass index, › 30; mean age, 62.2 years; 53.2% women), including 2995 also diagnosed with T2D, all enrolled in 2006-2010.
• Aerobic activity was defined as bouts lasting ≥ 3 minutes, and the intensity of activity was classified as light, moderate, or vigorous using accelerometer data collected from participants.
• Participants were stratified into the morning (6 a.m. to < 12 p.m.), afternoon (12 p.m. to < 6 p.m.), and evening (6 p.m. to < 12 a.m.) groups based on when > 50% of their total moderate to vigorous activity occurred, and those with no aerobic bouts were considered the reference group.
• The association between the timing of aerobic physical activity and risk for all-cause mortality, CVD (defined as circulatory, such as hypertension), and MVD (neuropathy, nephropathy, or retinopathy) was evaluated over a median follow-up of 7.9 years.

TAKEAWAY:

• Mortality risk was lowest in the evening moderate to vigorous physical activity group (hazard ratio [HR], 0.39; 95% CI, 0.27-0.55) and even lower in the T2D subgroup (HR, 0.24; 95% CI, 0.08-0.76) than in the reference group.
• Mortality risk was lower in the afternoon (HR, 0.60; 95% CI, 0.51-0.71) and morning (HR, 0.67; 95% CI, 0.56-0.79) activity groups than in the reference group, but this association was weaker than that observed in the evening activity group.
• The evening moderate to vigorous activity group had a lower risk for CVD (HR, 0.64; 95% CI, 0.54-0.75) and MVD (HR, 0.76; 95% CI, 0.63-0.92) than the reference group.
• Among participants with obesity and T2D, moderate to vigorous physical activity in the evening was associated with a lower risk for mortality, CVD, and MVD.

IN PRACTICE:

The authors wrote, “The results of this study emphasize that beyond the total volume of MVPA [moderate to vigorous physical activity], its timing, particularly in the evening, was consistently associated with the lowest risk of mortality relative to other timing windows.”

SOURCE:

The study, led by Angelo Sabag, PhD, Charles Perkins Centre, University of Sydney, Australia, was published online in Diabetes Care.

LIMITATIONS:

Because this was an observational study, the possibility of reverse causation from prodromal disease and unaccounted confounding factors could not have been ruled out. There was a lag of a median of 5.5 years between the UK Biobank baseline, when covariate measurements were taken, and the accelerometry study. Moreover, the response rate of the UK Biobank was low.

DISCLOSURES:

The study was funded by an Australian National Health and Medical Research Council Investigator Grant and the National Heart Foundation of Australia Postdoctoral Fellowship. The authors reported no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Signals for keratoacanthoma and cutaneous squamous cell carcinoma (cSCC) with programmed cell death 1 (PD-1) and programmed cell death ligand 1 (PD-L1) inhibitors were detected in an analysis of adverse events (AEs) reported to the US Food and Drug Administration (FDA).

METHODOLOGY:

• The risk for dermatologic immune-related side effects may be increased with immunologic-modifying drugs.
• To determine if there are significant signals between keratoacanthomas and cSCCs and PD-1/PD-L1 inhibitors, researchers analyzed AEs associated with these agents reported to the FDA’s Adverse Event Reporting System (FAERS) between January 2004 and May 2023.
• Pharmacovigilance signals were identified, and a significant signal was defined as the lower 95% CI of a reporting odds ratio (ROR) greater than one or the lower 95% CI of an information component (IC) greater than 0.

TAKEAWAY:

• Of the 158,000 reports of PD-1/PD-L1 inhibitor use, 43 were in patients who developed a keratoacanthoma (mean age, 77 years; 39% women) and 83 were in patients who developed cSCC (mean age, 71 years; 41% women). Patients aged 60-79 years were most likely to develop keratoacanthomas and cSCC on these treatments.
• A PD-1/PD-L1 inhibitor was listed as the suspect drug in all 43 keratoacanthoma reports and in 70 of 83 cSCC reports (the remaining 13 listed them as the concomitant drug).
• Significant signals were reported for both keratoacanthoma (ROR, 9.7; IC, 1.9) and cSCC (ROR, 3.0; IC, 0.9) with PD-1/PD-L1 inhibitor use.
• Of the reports where this information was available, all 10 cases of PD-1/PD-L1 inhibitor–linked keratoacanthoma and 10 of 17 cases (59%) of PD-1/PD-L1 inhibitor–linked cSCC, resolution was noted following discontinuation or dose reduction of the inhibitor.

IN PRACTICE:

“Given the large number of patients receiving immunotherapy, FAERS recording only 43 patients developing keratoacanthoma and 83 patients developing cSCC highlights that these conditions are relatively rare adverse events,” the authors wrote but added that more studies are needed to confirm these results.

SOURCE:

The study, led by Pushkar Aggarwal, MD, MBA, of the Department of Dermatology, University of Cincinnati, Cincinnati, Ohio, was published online in JAMA Dermatology.

LIMITATIONS:

The data obtained from FAERS did not contain information on all AEs from drugs. In addition, a causal association could not be determined.

DISCLOSURES:

The funding source was not reported. The authors did not report any conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Signals for keratoacanthoma and cutaneous squamous cell carcinoma (cSCC) with programmed cell death 1 (PD-1) and programmed cell death ligand 1 (PD-L1) inhibitors were detected in an analysis of adverse events (AEs) reported to the US Food and Drug Administration (FDA).

METHODOLOGY:

• The risk for dermatologic immune-related side effects may be increased with immunologic-modifying drugs.
• To determine if there are significant signals between keratoacanthomas and cSCCs and PD-1/PD-L1 inhibitors, researchers analyzed AEs associated with these agents reported to the FDA’s Adverse Event Reporting System (FAERS) between January 2004 and May 2023.
• Pharmacovigilance signals were identified, and a significant signal was defined as the lower 95% CI of a reporting odds ratio (ROR) greater than one or the lower 95% CI of an information component (IC) greater than 0.

TAKEAWAY:

• Of the 158,000 reports of PD-1/PD-L1 inhibitor use, 43 were in patients who developed a keratoacanthoma (mean age, 77 years; 39% women) and 83 were in patients who developed cSCC (mean age, 71 years; 41% women). Patients aged 60-79 years were most likely to develop keratoacanthomas and cSCC on these treatments.
• A PD-1/PD-L1 inhibitor was listed as the suspect drug in all 43 keratoacanthoma reports and in 70 of 83 cSCC reports (the remaining 13 listed them as the concomitant drug).
• Significant signals were reported for both keratoacanthoma (ROR, 9.7; IC, 1.9) and cSCC (ROR, 3.0; IC, 0.9) with PD-1/PD-L1 inhibitor use.
• Of the reports where this information was available, all 10 cases of PD-1/PD-L1 inhibitor–linked keratoacanthoma and 10 of 17 cases (59%) of PD-1/PD-L1 inhibitor–linked cSCC, resolution was noted following discontinuation or dose reduction of the inhibitor.

IN PRACTICE:

“Given the large number of patients receiving immunotherapy, FAERS recording only 43 patients developing keratoacanthoma and 83 patients developing cSCC highlights that these conditions are relatively rare adverse events,” the authors wrote but added that more studies are needed to confirm these results.

SOURCE:

The study, led by Pushkar Aggarwal, MD, MBA, of the Department of Dermatology, University of Cincinnati, Cincinnati, Ohio, was published online in JAMA Dermatology.

LIMITATIONS:

The data obtained from FAERS did not contain information on all AEs from drugs. In addition, a causal association could not be determined.

DISCLOSURES:

The funding source was not reported. The authors did not report any conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Signals for keratoacanthoma and cutaneous squamous cell carcinoma (cSCC) with programmed cell death 1 (PD-1) and programmed cell death ligand 1 (PD-L1) inhibitors were detected in an analysis of adverse events (AEs) reported to the US Food and Drug Administration (FDA).

METHODOLOGY:

• The risk for dermatologic immune-related side effects may be increased with immunologic-modifying drugs.
• To determine if there are significant signals between keratoacanthomas and cSCCs and PD-1/PD-L1 inhibitors, researchers analyzed AEs associated with these agents reported to the FDA’s Adverse Event Reporting System (FAERS) between January 2004 and May 2023.
• Pharmacovigilance signals were identified, and a significant signal was defined as the lower 95% CI of a reporting odds ratio (ROR) greater than one or the lower 95% CI of an information component (IC) greater than 0.

TAKEAWAY:

• Of the 158,000 reports of PD-1/PD-L1 inhibitor use, 43 were in patients who developed a keratoacanthoma (mean age, 77 years; 39% women) and 83 were in patients who developed cSCC (mean age, 71 years; 41% women). Patients aged 60-79 years were most likely to develop keratoacanthomas and cSCC on these treatments.
• A PD-1/PD-L1 inhibitor was listed as the suspect drug in all 43 keratoacanthoma reports and in 70 of 83 cSCC reports (the remaining 13 listed them as the concomitant drug).
• Significant signals were reported for both keratoacanthoma (ROR, 9.7; IC, 1.9) and cSCC (ROR, 3.0; IC, 0.9) with PD-1/PD-L1 inhibitor use.
• Of the reports where this information was available, all 10 cases of PD-1/PD-L1 inhibitor–linked keratoacanthoma and 10 of 17 cases (59%) of PD-1/PD-L1 inhibitor–linked cSCC, resolution was noted following discontinuation or dose reduction of the inhibitor.

IN PRACTICE:

“Given the large number of patients receiving immunotherapy, FAERS recording only 43 patients developing keratoacanthoma and 83 patients developing cSCC highlights that these conditions are relatively rare adverse events,” the authors wrote but added that more studies are needed to confirm these results.

SOURCE:

The study, led by Pushkar Aggarwal, MD, MBA, of the Department of Dermatology, University of Cincinnati, Cincinnati, Ohio, was published online in JAMA Dermatology.

LIMITATIONS:

The data obtained from FAERS did not contain information on all AEs from drugs. In addition, a causal association could not be determined.

DISCLOSURES:

The funding source was not reported. The authors did not report any conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Combined pediatric dermatology-rheumatology clinics can improve patient care and patient satisfaction, a survey of dermatologists suggested.

METHODOLOGY:

• Combined pediatric dermatology-rheumatology clinics can improve patient outcomes and experiences, particularly for pediatric autoimmune conditions presenting with both cutaneous and systemic manifestations.
• The researchers surveyed 208 pediatric dermatologists working in combined pediatric dermatology-rheumatology clinics.
• A total of 13 member responses were recorded from three countries: 10 from the United States, two from Mexico, and one from Canada.

TAKEAWAY:

• Perceived benefits of combined clinics were improved patient care through coordinated treatment decisions and timely communication between providers.
• Patient satisfaction was favorable, and patients and families endorsed the combined clinic approach.
• Barriers to clinic establishment included differences in the pace between dermatology and rheumatology clinic flow, the need to generate more relative value units, resistance from colleagues, and limited time.
• Areas that needed improvement included more time for patient visits, dedicated research assistants, new patient referrals, additional patient rooms, resources for research, and patient care infrastructure.

IN PRACTICE:

The insights from this survey “will hopefully inspire further development of these combined clinics,” the authors wrote.

SOURCE:

The investigation, led by Olga S. Cherepakhin, BS, University of Washington, Seattle, Washington, was published in Pediatric Dermatology.

LIMITATIONS:

Limitations included the subjective nature, lack of some information, selection bias, and small number of respondents, and the survey reflected the perspective of the pediatric dermatologists only.

DISCLOSURES:

The study was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. One author reported full-time employment at Janssen R&D, and the other authors had no disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Combined pediatric dermatology-rheumatology clinics can improve patient care and patient satisfaction, a survey of dermatologists suggested.

METHODOLOGY:

• Combined pediatric dermatology-rheumatology clinics can improve patient outcomes and experiences, particularly for pediatric autoimmune conditions presenting with both cutaneous and systemic manifestations.
• The researchers surveyed 208 pediatric dermatologists working in combined pediatric dermatology-rheumatology clinics.
• A total of 13 member responses were recorded from three countries: 10 from the United States, two from Mexico, and one from Canada.

TAKEAWAY:

• Perceived benefits of combined clinics were improved patient care through coordinated treatment decisions and timely communication between providers.
• Patient satisfaction was favorable, and patients and families endorsed the combined clinic approach.
• Barriers to clinic establishment included differences in the pace between dermatology and rheumatology clinic flow, the need to generate more relative value units, resistance from colleagues, and limited time.
• Areas that needed improvement included more time for patient visits, dedicated research assistants, new patient referrals, additional patient rooms, resources for research, and patient care infrastructure.

IN PRACTICE:

The insights from this survey “will hopefully inspire further development of these combined clinics,” the authors wrote.

SOURCE:

The investigation, led by Olga S. Cherepakhin, BS, University of Washington, Seattle, Washington, was published in Pediatric Dermatology.

LIMITATIONS:

Limitations included the subjective nature, lack of some information, selection bias, and small number of respondents, and the survey reflected the perspective of the pediatric dermatologists only.

DISCLOSURES:

The study was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. One author reported full-time employment at Janssen R&D, and the other authors had no disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Combined pediatric dermatology-rheumatology clinics can improve patient care and patient satisfaction, a survey of dermatologists suggested.

METHODOLOGY:

• Combined pediatric dermatology-rheumatology clinics can improve patient outcomes and experiences, particularly for pediatric autoimmune conditions presenting with both cutaneous and systemic manifestations.
• The researchers surveyed 208 pediatric dermatologists working in combined pediatric dermatology-rheumatology clinics.
• A total of 13 member responses were recorded from three countries: 10 from the United States, two from Mexico, and one from Canada.

TAKEAWAY:

• Perceived benefits of combined clinics were improved patient care through coordinated treatment decisions and timely communication between providers.
• Patient satisfaction was favorable, and patients and families endorsed the combined clinic approach.
• Barriers to clinic establishment included differences in the pace between dermatology and rheumatology clinic flow, the need to generate more relative value units, resistance from colleagues, and limited time.
• Areas that needed improvement included more time for patient visits, dedicated research assistants, new patient referrals, additional patient rooms, resources for research, and patient care infrastructure.

IN PRACTICE:

The insights from this survey “will hopefully inspire further development of these combined clinics,” the authors wrote.

SOURCE:

The investigation, led by Olga S. Cherepakhin, BS, University of Washington, Seattle, Washington, was published in Pediatric Dermatology.

LIMITATIONS:

Limitations included the subjective nature, lack of some information, selection bias, and small number of respondents, and the survey reflected the perspective of the pediatric dermatologists only.

DISCLOSURES:

The study was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health. One author reported full-time employment at Janssen R&D, and the other authors had no disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

A low-fat vegan diet — high in fiber and carbohydrates and moderate in protein — reduces insulin requirement, increases insulin sensitivity, and improves glycemic control in individuals with type 1 diabetes (T1D) compared with a conventional portion-controlled diet.

METHODOLOGY:

• The effects of a low-fat vegan diet (without carbohydrate or portion restriction) were compared with those of a conventional portion-controlled, carbohydrate-controlled diet in 58 patients with T1D (age, ≥ 18 years) who had been receiving stable insulin treatment for the past 3 months.
• Participants were randomly assigned to receive either the vegan diet (n = 29), comprising vegetables, grains, legumes, and fruits, or the portion-controlled diet (n = 29), which reduced daily energy intake by 500-1000 kcal/d in participants with overweight while maintaining a stable carbohydrate intake.
• The primary clinical outcomes were insulin requirement (total daily dose of insulin), insulin sensitivity, and glycemic control (A1c).
• Other assessments included the blood, lipid profile, blood urea nitrogen, blood urea nitrogen-to-creatinine ratio, and body weight.

TAKEAWAY:

• The study was completed by 18 participants in the vegan-diet group and 17 in the portion-controlled group.
• In the vegan group, the total daily dose of insulin decreased by 12.1 units/d (P = .007) and insulin sensitivity increased by 6.6 g of carbohydrate per unit of insulin on average (P = .002), with no significant changes in the portion-controlled diet group.
• Participants on the vegan diet had lower levels of total and low-density lipoprotein cholesterol and blood urea nitrogen and a lower blood urea nitrogen-to-creatinine ratio (P for all < .001), whereas both vegan and portion-controlled groups had lower A1c levels.
• Body weight decreased by 5.2 kg (P < .001) in the vegan group; there were no significant changes in the portion-controlled group.
• For every 1-kg weight loss, there was a 2.16-unit decrease in the insulin total daily dose and a 0.9-unit increase in insulin sensitivity.

IN PRACTICE:

“This study provides substantial support for a low-fat vegan diet that is high in fiber and carbohydrates, low in fat, and moderate in protein” and suggests the potential therapeutic use of this diet in type 1 diabetes management, the authors wrote.

SOURCE:

The study led by Hana Kahleova, MD, PhD, Physicians Committee for Responsible Medicine, Washington, was published in Clinical Diabetes.

LIMITATIONS:

Dietary intake was recorded on the basis of self-reported data. A higher attrition rate was observed due to meal and blood glucose monitoring. The findings may have limited generalizability as the study participants comprised those seeking help for T1D.

DISCLOSURES:

The study was supported by the Physicians Committee for Responsible Medicine and a grant from the Institute for Technology in Healthcare. Some authors reported receiving compensation, being cofounders of a coaching program, writing books, providing nutrition coaching, giving lectures, or receiving royalties and honoraria from various sources.

A version of this article appeared on Medscape.com.

TOPLINE:

A low-fat vegan diet — high in fiber and carbohydrates and moderate in protein — reduces insulin requirement, increases insulin sensitivity, and improves glycemic control in individuals with type 1 diabetes (T1D) compared with a conventional portion-controlled diet.

METHODOLOGY:

• The effects of a low-fat vegan diet (without carbohydrate or portion restriction) were compared with those of a conventional portion-controlled, carbohydrate-controlled diet in 58 patients with T1D (age, ≥ 18 years) who had been receiving stable insulin treatment for the past 3 months.
• Participants were randomly assigned to receive either the vegan diet (n = 29), comprising vegetables, grains, legumes, and fruits, or the portion-controlled diet (n = 29), which reduced daily energy intake by 500-1000 kcal/d in participants with overweight while maintaining a stable carbohydrate intake.
• The primary clinical outcomes were insulin requirement (total daily dose of insulin), insulin sensitivity, and glycemic control (A1c).
• Other assessments included the blood, lipid profile, blood urea nitrogen, blood urea nitrogen-to-creatinine ratio, and body weight.

TAKEAWAY:

• The study was completed by 18 participants in the vegan-diet group and 17 in the portion-controlled group.
• In the vegan group, the total daily dose of insulin decreased by 12.1 units/d (P = .007) and insulin sensitivity increased by 6.6 g of carbohydrate per unit of insulin on average (P = .002), with no significant changes in the portion-controlled diet group.
• Participants on the vegan diet had lower levels of total and low-density lipoprotein cholesterol and blood urea nitrogen and a lower blood urea nitrogen-to-creatinine ratio (P for all < .001), whereas both vegan and portion-controlled groups had lower A1c levels.
• Body weight decreased by 5.2 kg (P < .001) in the vegan group; there were no significant changes in the portion-controlled group.
• For every 1-kg weight loss, there was a 2.16-unit decrease in the insulin total daily dose and a 0.9-unit increase in insulin sensitivity.

IN PRACTICE:

“This study provides substantial support for a low-fat vegan diet that is high in fiber and carbohydrates, low in fat, and moderate in protein” and suggests the potential therapeutic use of this diet in type 1 diabetes management, the authors wrote.

SOURCE:

The study led by Hana Kahleova, MD, PhD, Physicians Committee for Responsible Medicine, Washington, was published in Clinical Diabetes.

LIMITATIONS:

Dietary intake was recorded on the basis of self-reported data. A higher attrition rate was observed due to meal and blood glucose monitoring. The findings may have limited generalizability as the study participants comprised those seeking help for T1D.

DISCLOSURES:

The study was supported by the Physicians Committee for Responsible Medicine and a grant from the Institute for Technology in Healthcare. Some authors reported receiving compensation, being cofounders of a coaching program, writing books, providing nutrition coaching, giving lectures, or receiving royalties and honoraria from various sources.

A version of this article appeared on Medscape.com.

TOPLINE:

A low-fat vegan diet — high in fiber and carbohydrates and moderate in protein — reduces insulin requirement, increases insulin sensitivity, and improves glycemic control in individuals with type 1 diabetes (T1D) compared with a conventional portion-controlled diet.

METHODOLOGY:

• The effects of a low-fat vegan diet (without carbohydrate or portion restriction) were compared with those of a conventional portion-controlled, carbohydrate-controlled diet in 58 patients with T1D (age, ≥ 18 years) who had been receiving stable insulin treatment for the past 3 months.
• Participants were randomly assigned to receive either the vegan diet (n = 29), comprising vegetables, grains, legumes, and fruits, or the portion-controlled diet (n = 29), which reduced daily energy intake by 500-1000 kcal/d in participants with overweight while maintaining a stable carbohydrate intake.
• The primary clinical outcomes were insulin requirement (total daily dose of insulin), insulin sensitivity, and glycemic control (A1c).
• Other assessments included the blood, lipid profile, blood urea nitrogen, blood urea nitrogen-to-creatinine ratio, and body weight.

TAKEAWAY:

• The study was completed by 18 participants in the vegan-diet group and 17 in the portion-controlled group.
• In the vegan group, the total daily dose of insulin decreased by 12.1 units/d (P = .007) and insulin sensitivity increased by 6.6 g of carbohydrate per unit of insulin on average (P = .002), with no significant changes in the portion-controlled diet group.
• Participants on the vegan diet had lower levels of total and low-density lipoprotein cholesterol and blood urea nitrogen and a lower blood urea nitrogen-to-creatinine ratio (P for all < .001), whereas both vegan and portion-controlled groups had lower A1c levels.
• Body weight decreased by 5.2 kg (P < .001) in the vegan group; there were no significant changes in the portion-controlled group.
• For every 1-kg weight loss, there was a 2.16-unit decrease in the insulin total daily dose and a 0.9-unit increase in insulin sensitivity.

IN PRACTICE:

“This study provides substantial support for a low-fat vegan diet that is high in fiber and carbohydrates, low in fat, and moderate in protein” and suggests the potential therapeutic use of this diet in type 1 diabetes management, the authors wrote.

SOURCE:

The study led by Hana Kahleova, MD, PhD, Physicians Committee for Responsible Medicine, Washington, was published in Clinical Diabetes.

LIMITATIONS:

Dietary intake was recorded on the basis of self-reported data. A higher attrition rate was observed due to meal and blood glucose monitoring. The findings may have limited generalizability as the study participants comprised those seeking help for T1D.

DISCLOSURES:

The study was supported by the Physicians Committee for Responsible Medicine and a grant from the Institute for Technology in Healthcare. Some authors reported receiving compensation, being cofounders of a coaching program, writing books, providing nutrition coaching, giving lectures, or receiving royalties and honoraria from various sources.

A version of this article appeared on Medscape.com.

TOPLINE:

Monthly cycles of a fasting-mimicking diet (FMD) may slow metabolic and immune system aging and reduce the risk for metabolic disease.

METHODOLOGY:

• In two clinical trials, monthly 5-day cycles of an FMD (a proprietary line of plant-based, low-calorie, and low-protein food products) showed lower body weight, body fat, and blood pressure at 3 months.
• Researchers assessed secondary outcomes for the impact of the diet on risk factors for metabolic syndrome and biomarkers associated with aging and age-related diseases.
• This study looked at data from nearly half of the original 184 participants (aged 18-70 years) from the two clinical trials who went through three to four monthly cycles, adhering to 5 days of an FMD in either a crossover design compared with a normal diet or an intervention group compared with people following a Mediterranean diet.
• Abdominal fat and hepatic fat were measured using an MRI in a subset of representative participants. The study also assessed metabolic blood markers and lipids and lymphoid-to-myeloid ratios (for immune aging).
• Biological age estimation was calculated from seven clinical chemistry measures, and life expectancy and mortality risk estimates and a simulation of continued FMD cycles were based on the National Health and Nutrition Examination Survey.

TAKEAWAY:

• In 15 volunteers measured by MRI, the body mass index (P = .0002), total body fat (P = .002), subcutaneous adipose tissue (P = .008), visceral adipose tissue (P = .002), and hepatic fat fraction (P = .049) reduced after the third FMD cycle, with a 50% reduction in liver fat for the five people with hepatic steatosis.
• In 11 participants with prediabetes, insulin resistance (measured by homeostatic model assessment) reduced from 1.473 to 1.209 (P = .046), while A1c levels dropped from 5.8 to 5.43 (P = .032) after the third FMD cycle.

• The lymphoid-to-myeloid ratio improved (P = .005) in all study participants receiving three FMD cycles, indicating an immune aging reversal.
• The estimated median biological age of the 86 participants who completed three FMD cycles in both trials decreased by nearly 2.5 years, independent of weight loss.

IN PRACTICE:

“Together our findings indicate that the FMD is a feasible periodic dietary intervention that reduces disease risk factors and biological age,” the authors wrote.

SOURCE:

The study, led by Sebastian Brandhorst, PhD, Leonard Davis School of Gerontology, University of Southern California (USC), Los Angeles, and Morgan E. Levine, PhD, Department of Pathology, Yale School of Medicine, New Haven, Connecticut, was published in Nature Communications.

LIMITATIONS:

The study estimated the effects of monthly FMD cycles based on results from two clinical trials and included a small subset of trial volunteers. By study measures, the cohort was healthier and biologically younger than average people of similar chronological age. Of the 86 participants, 24 who underwent FMD cycles exhibited increased biological age. The simulation did not consider compliance, dropout, mortality, or the bias that may arise owing to enthusiastic volunteers. Estimated risk reductions assume an effect of change in biological age, which hasn’t been proven. Projections from extending the effects of FMD to a lifelong intervention may require cautious interpretation.

DISCLOSURES:

The study was supported by the USC Edna Jones chair fund and funds from NIH/NIA and the Yale PEPPER Center. The experimental diet was provided by L-Nutra Inc. Some authors declared an equity interest in L-Nutra, with one author’s equity to be assigned to the nonprofit foundation Create Cures. Others disclosed no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Monthly cycles of a fasting-mimicking diet (FMD) may slow metabolic and immune system aging and reduce the risk for metabolic disease.

METHODOLOGY:

• In two clinical trials, monthly 5-day cycles of an FMD (a proprietary line of plant-based, low-calorie, and low-protein food products) showed lower body weight, body fat, and blood pressure at 3 months.
• Researchers assessed secondary outcomes for the impact of the diet on risk factors for metabolic syndrome and biomarkers associated with aging and age-related diseases.
• This study looked at data from nearly half of the original 184 participants (aged 18-70 years) from the two clinical trials who went through three to four monthly cycles, adhering to 5 days of an FMD in either a crossover design compared with a normal diet or an intervention group compared with people following a Mediterranean diet.
• Abdominal fat and hepatic fat were measured using an MRI in a subset of representative participants. The study also assessed metabolic blood markers and lipids and lymphoid-to-myeloid ratios (for immune aging).
• Biological age estimation was calculated from seven clinical chemistry measures, and life expectancy and mortality risk estimates and a simulation of continued FMD cycles were based on the National Health and Nutrition Examination Survey.

TAKEAWAY:

• In 15 volunteers measured by MRI, the body mass index (P = .0002), total body fat (P = .002), subcutaneous adipose tissue (P = .008), visceral adipose tissue (P = .002), and hepatic fat fraction (P = .049) reduced after the third FMD cycle, with a 50% reduction in liver fat for the five people with hepatic steatosis.
• In 11 participants with prediabetes, insulin resistance (measured by homeostatic model assessment) reduced from 1.473 to 1.209 (P = .046), while A1c levels dropped from 5.8 to 5.43 (P = .032) after the third FMD cycle.

• The lymphoid-to-myeloid ratio improved (P = .005) in all study participants receiving three FMD cycles, indicating an immune aging reversal.
• The estimated median biological age of the 86 participants who completed three FMD cycles in both trials decreased by nearly 2.5 years, independent of weight loss.

IN PRACTICE:

“Together our findings indicate that the FMD is a feasible periodic dietary intervention that reduces disease risk factors and biological age,” the authors wrote.

SOURCE:

The study, led by Sebastian Brandhorst, PhD, Leonard Davis School of Gerontology, University of Southern California (USC), Los Angeles, and Morgan E. Levine, PhD, Department of Pathology, Yale School of Medicine, New Haven, Connecticut, was published in Nature Communications.

LIMITATIONS:

The study estimated the effects of monthly FMD cycles based on results from two clinical trials and included a small subset of trial volunteers. By study measures, the cohort was healthier and biologically younger than average people of similar chronological age. Of the 86 participants, 24 who underwent FMD cycles exhibited increased biological age. The simulation did not consider compliance, dropout, mortality, or the bias that may arise owing to enthusiastic volunteers. Estimated risk reductions assume an effect of change in biological age, which hasn’t been proven. Projections from extending the effects of FMD to a lifelong intervention may require cautious interpretation.

DISCLOSURES:

The study was supported by the USC Edna Jones chair fund and funds from NIH/NIA and the Yale PEPPER Center. The experimental diet was provided by L-Nutra Inc. Some authors declared an equity interest in L-Nutra, with one author’s equity to be assigned to the nonprofit foundation Create Cures. Others disclosed no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Monthly cycles of a fasting-mimicking diet (FMD) may slow metabolic and immune system aging and reduce the risk for metabolic disease.

METHODOLOGY:

• In two clinical trials, monthly 5-day cycles of an FMD (a proprietary line of plant-based, low-calorie, and low-protein food products) showed lower body weight, body fat, and blood pressure at 3 months.
• Researchers assessed secondary outcomes for the impact of the diet on risk factors for metabolic syndrome and biomarkers associated with aging and age-related diseases.
• This study looked at data from nearly half of the original 184 participants (aged 18-70 years) from the two clinical trials who went through three to four monthly cycles, adhering to 5 days of an FMD in either a crossover design compared with a normal diet or an intervention group compared with people following a Mediterranean diet.
• Abdominal fat and hepatic fat were measured using an MRI in a subset of representative participants. The study also assessed metabolic blood markers and lipids and lymphoid-to-myeloid ratios (for immune aging).
• Biological age estimation was calculated from seven clinical chemistry measures, and life expectancy and mortality risk estimates and a simulation of continued FMD cycles were based on the National Health and Nutrition Examination Survey.

TAKEAWAY:

• In 15 volunteers measured by MRI, the body mass index (P = .0002), total body fat (P = .002), subcutaneous adipose tissue (P = .008), visceral adipose tissue (P = .002), and hepatic fat fraction (P = .049) reduced after the third FMD cycle, with a 50% reduction in liver fat for the five people with hepatic steatosis.
• In 11 participants with prediabetes, insulin resistance (measured by homeostatic model assessment) reduced from 1.473 to 1.209 (P = .046), while A1c levels dropped from 5.8 to 5.43 (P = .032) after the third FMD cycle.

• The lymphoid-to-myeloid ratio improved (P = .005) in all study participants receiving three FMD cycles, indicating an immune aging reversal.
• The estimated median biological age of the 86 participants who completed three FMD cycles in both trials decreased by nearly 2.5 years, independent of weight loss.

IN PRACTICE:

“Together our findings indicate that the FMD is a feasible periodic dietary intervention that reduces disease risk factors and biological age,” the authors wrote.

SOURCE:

The study, led by Sebastian Brandhorst, PhD, Leonard Davis School of Gerontology, University of Southern California (USC), Los Angeles, and Morgan E. Levine, PhD, Department of Pathology, Yale School of Medicine, New Haven, Connecticut, was published in Nature Communications.

LIMITATIONS:

The study estimated the effects of monthly FMD cycles based on results from two clinical trials and included a small subset of trial volunteers. By study measures, the cohort was healthier and biologically younger than average people of similar chronological age. Of the 86 participants, 24 who underwent FMD cycles exhibited increased biological age. The simulation did not consider compliance, dropout, mortality, or the bias that may arise owing to enthusiastic volunteers. Estimated risk reductions assume an effect of change in biological age, which hasn’t been proven. Projections from extending the effects of FMD to a lifelong intervention may require cautious interpretation.

DISCLOSURES:

The study was supported by the USC Edna Jones chair fund and funds from NIH/NIA and the Yale PEPPER Center. The experimental diet was provided by L-Nutra Inc. Some authors declared an equity interest in L-Nutra, with one author’s equity to be assigned to the nonprofit foundation Create Cures. Others disclosed no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Long naps of an hour or more, naps in the morning, or regular siestas may increase blood glucose levels in older people with type 2 diabetes (T2D).

METHODOLOGY:

• Napping is common in China and other cultures and may play a role in cardiometabolic health, but previous studies on the relationship between napping and glycemic control in T2D have reported conflicting results.
• In a cross-sectional study, the researchers assessed 226 individuals with T2D (median age, 67 years; about half women; mostly retired) from two community healthcare centers in China between May 2023 and July 2023.
• Using questionnaires, the participants were evaluated for A1c levels, as well as frequency, duration (shorter or longer than 1 hour), timing, and type of napping behavior (restorative for lack of sleep vs appetitive by habit or for enjoyment).
• Multivariate analysis controlled for age, sex, body mass index, T2D treatment regimen, diabetes duration, cognitive impairment, depression, night sleep duration, and insomnia symptoms.

TAKEAWAY:

• Among 180 participants who reported napping, 61 (33.9%) took long naps of 60 minutes and more, 162 (90%) reported afternoon napping, and 131 (72.8%) displayed appetitive napping.
• Restorative napping was linked to lower A1c levels than appetitive napping (β, −0.176; P = 0.028).
• Napping frequency was not associated with A1c levels.

IN PRACTICE:

“In clinical practice, healthcare professionals may offer tips about napping, eg, taking a nap less than an hour, taking a nap in the afternoon instead of in the morning, avoiding appetitive napping,” the authors concluded.

SOURCE:

The study, from corresponding author Bingqian Zhu, PhD, of the Shanghai Jiao Tong University School of Nursing, Shanghai, was published in Frontiers in Endocrinology.

LIMITATIONS:

The participants were older individuals, mostly retired, who may have had less need for restorative napping and more time for appetitive napping, limiting generalizability. The sample size may have been too small to find a link to napping frequency. Self-reported data could introduce recall bias. Only A1c levels were used as a measure of glycemic control.

DISCLOSURES:

The study was supported by the National Natural Science Foundation of China and other sources. The authors declared no potential conflict of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Long naps of an hour or more, naps in the morning, or regular siestas may increase blood glucose levels in older people with type 2 diabetes (T2D).

METHODOLOGY:

• Napping is common in China and other cultures and may play a role in cardiometabolic health, but previous studies on the relationship between napping and glycemic control in T2D have reported conflicting results.
• In a cross-sectional study, the researchers assessed 226 individuals with T2D (median age, 67 years; about half women; mostly retired) from two community healthcare centers in China between May 2023 and July 2023.
• Using questionnaires, the participants were evaluated for A1c levels, as well as frequency, duration (shorter or longer than 1 hour), timing, and type of napping behavior (restorative for lack of sleep vs appetitive by habit or for enjoyment).
• Multivariate analysis controlled for age, sex, body mass index, T2D treatment regimen, diabetes duration, cognitive impairment, depression, night sleep duration, and insomnia symptoms.

TAKEAWAY:

• Among 180 participants who reported napping, 61 (33.9%) took long naps of 60 minutes and more, 162 (90%) reported afternoon napping, and 131 (72.8%) displayed appetitive napping.
• Restorative napping was linked to lower A1c levels than appetitive napping (β, −0.176; P = 0.028).
• Napping frequency was not associated with A1c levels.

IN PRACTICE:

“In clinical practice, healthcare professionals may offer tips about napping, eg, taking a nap less than an hour, taking a nap in the afternoon instead of in the morning, avoiding appetitive napping,” the authors concluded.

SOURCE:

The study, from corresponding author Bingqian Zhu, PhD, of the Shanghai Jiao Tong University School of Nursing, Shanghai, was published in Frontiers in Endocrinology.

LIMITATIONS:

The participants were older individuals, mostly retired, who may have had less need for restorative napping and more time for appetitive napping, limiting generalizability. The sample size may have been too small to find a link to napping frequency. Self-reported data could introduce recall bias. Only A1c levels were used as a measure of glycemic control.

DISCLOSURES:

The study was supported by the National Natural Science Foundation of China and other sources. The authors declared no potential conflict of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Long naps of an hour or more, naps in the morning, or regular siestas may increase blood glucose levels in older people with type 2 diabetes (T2D).

METHODOLOGY:

• Napping is common in China and other cultures and may play a role in cardiometabolic health, but previous studies on the relationship between napping and glycemic control in T2D have reported conflicting results.
• In a cross-sectional study, the researchers assessed 226 individuals with T2D (median age, 67 years; about half women; mostly retired) from two community healthcare centers in China between May 2023 and July 2023.
• Using questionnaires, the participants were evaluated for A1c levels, as well as frequency, duration (shorter or longer than 1 hour), timing, and type of napping behavior (restorative for lack of sleep vs appetitive by habit or for enjoyment).
• Multivariate analysis controlled for age, sex, body mass index, T2D treatment regimen, diabetes duration, cognitive impairment, depression, night sleep duration, and insomnia symptoms.

TAKEAWAY:

• Among 180 participants who reported napping, 61 (33.9%) took long naps of 60 minutes and more, 162 (90%) reported afternoon napping, and 131 (72.8%) displayed appetitive napping.
• Restorative napping was linked to lower A1c levels than appetitive napping (β, −0.176; P = 0.028).
• Napping frequency was not associated with A1c levels.

IN PRACTICE:

“In clinical practice, healthcare professionals may offer tips about napping, eg, taking a nap less than an hour, taking a nap in the afternoon instead of in the morning, avoiding appetitive napping,” the authors concluded.

SOURCE:

The study, from corresponding author Bingqian Zhu, PhD, of the Shanghai Jiao Tong University School of Nursing, Shanghai, was published in Frontiers in Endocrinology.

LIMITATIONS:

The participants were older individuals, mostly retired, who may have had less need for restorative napping and more time for appetitive napping, limiting generalizability. The sample size may have been too small to find a link to napping frequency. Self-reported data could introduce recall bias. Only A1c levels were used as a measure of glycemic control.

DISCLOSURES:

The study was supported by the National Natural Science Foundation of China and other sources. The authors declared no potential conflict of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Inflammatory bowel disease (IBD) therapies for patients may need to be briefly halted during treatment for COVID-19, but it does not escalate IBD flares, with prior vaccination for COVID-19 helping reduce complications from the virus.

METHODOLOGY:

• Patients with IBD who receive immunosuppressive agents are at an increased risk of developing severe SARS-CoV-2 infection; however, the effects of COVID-19 vaccination and treatment on the outcomes in patients with IBD are less known.
• Researchers assessed the effect of COVID-19 medications in 127 patients with IBD (age ≥ 18 years; 54% women) who were diagnosed with COVID-19 after the advent of vaccines and release of antiviral therapies.
• Patients were stratified into those who received treatment for COVID-19 (n = 44), defined as the use of antivirals and/or intravenous antibodies, and those who did not receive treatment for COVID-19 (n = 83).
• The primary outcome was the development of a severe SARS-CoV-2 infection (defined by the need for oxygen supplements, corticosteroids and/or antibiotic treatment, or hospitalization).
• The secondary outcomes were the percentage of patients who had their IBD therapy withheld and rates of IBD flare post COVID-19.

TAKEAWAY:

• The likelihood of being treated for COVID-19 was higher in patients on corticosteroids (odds ratio [OR], 4.61; P = .002) or in those undergoing advanced IBD therapies (OR, 2.78; P = .041) prior to infection.
• Advanced age at the time of infection (adjusted OR [aOR], 1.06; P = .018) and corticosteroid treatment prior to contracting COVID-19 (aOR, 9.86; P = .001) were associated with an increased risk for severe infection.
• After adjustment for multiple factors, the likelihood of withholding IBD treatment was higher in patients being treated for COVID-19 (aOR, 6.95; P = .007).

IN PRACTICE:

“Patients with IBD on advanced therapies were frequently treated for acute COVID-19. Although COVID-19 treatment was associated with temporary withholding of IBD therapy, it did not result in increased IBD flares,” the authors wrote.

SOURCE:

The investigation, led by Laura C. Sahyoun, MD, Section of Digestive Diseases, Yale School of Medicine, New Haven, Connecticut, was published online in Digestive Diseases and Sciences.

LIMITATIONS:

Owing to the small sample size, the outcomes comparing antivirals to intravenous antibodies and SARS-CoV-2 strain prevalence could not be assessed. This single-center study also may not reflect the different clinical practices pertaining to IBD and COVID-19 treatments.

DISCLOSURES:

The study did not receive any specific funding. One author reported receiving speaker fees and being part of advisory boards, and another author received research support and reported being a part of advisory boards.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Inflammatory bowel disease (IBD) therapies for patients may need to be briefly halted during treatment for COVID-19, but it does not escalate IBD flares, with prior vaccination for COVID-19 helping reduce complications from the virus.

METHODOLOGY:

• Patients with IBD who receive immunosuppressive agents are at an increased risk of developing severe SARS-CoV-2 infection; however, the effects of COVID-19 vaccination and treatment on the outcomes in patients with IBD are less known.
• Researchers assessed the effect of COVID-19 medications in 127 patients with IBD (age ≥ 18 years; 54% women) who were diagnosed with COVID-19 after the advent of vaccines and release of antiviral therapies.
• Patients were stratified into those who received treatment for COVID-19 (n = 44), defined as the use of antivirals and/or intravenous antibodies, and those who did not receive treatment for COVID-19 (n = 83).
• The primary outcome was the development of a severe SARS-CoV-2 infection (defined by the need for oxygen supplements, corticosteroids and/or antibiotic treatment, or hospitalization).
• The secondary outcomes were the percentage of patients who had their IBD therapy withheld and rates of IBD flare post COVID-19.

TAKEAWAY:

• The likelihood of being treated for COVID-19 was higher in patients on corticosteroids (odds ratio [OR], 4.61; P = .002) or in those undergoing advanced IBD therapies (OR, 2.78; P = .041) prior to infection.
• Advanced age at the time of infection (adjusted OR [aOR], 1.06; P = .018) and corticosteroid treatment prior to contracting COVID-19 (aOR, 9.86; P = .001) were associated with an increased risk for severe infection.
• After adjustment for multiple factors, the likelihood of withholding IBD treatment was higher in patients being treated for COVID-19 (aOR, 6.95; P = .007).

IN PRACTICE:

“Patients with IBD on advanced therapies were frequently treated for acute COVID-19. Although COVID-19 treatment was associated with temporary withholding of IBD therapy, it did not result in increased IBD flares,” the authors wrote.

SOURCE:

The investigation, led by Laura C. Sahyoun, MD, Section of Digestive Diseases, Yale School of Medicine, New Haven, Connecticut, was published online in Digestive Diseases and Sciences.

LIMITATIONS:

Owing to the small sample size, the outcomes comparing antivirals to intravenous antibodies and SARS-CoV-2 strain prevalence could not be assessed. This single-center study also may not reflect the different clinical practices pertaining to IBD and COVID-19 treatments.

DISCLOSURES:

The study did not receive any specific funding. One author reported receiving speaker fees and being part of advisory boards, and another author received research support and reported being a part of advisory boards.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Inflammatory bowel disease (IBD) therapies for patients may need to be briefly halted during treatment for COVID-19, but it does not escalate IBD flares, with prior vaccination for COVID-19 helping reduce complications from the virus.

METHODOLOGY:

• Patients with IBD who receive immunosuppressive agents are at an increased risk of developing severe SARS-CoV-2 infection; however, the effects of COVID-19 vaccination and treatment on the outcomes in patients with IBD are less known.
• Researchers assessed the effect of COVID-19 medications in 127 patients with IBD (age ≥ 18 years; 54% women) who were diagnosed with COVID-19 after the advent of vaccines and release of antiviral therapies.
• Patients were stratified into those who received treatment for COVID-19 (n = 44), defined as the use of antivirals and/or intravenous antibodies, and those who did not receive treatment for COVID-19 (n = 83).
• The primary outcome was the development of a severe SARS-CoV-2 infection (defined by the need for oxygen supplements, corticosteroids and/or antibiotic treatment, or hospitalization).
• The secondary outcomes were the percentage of patients who had their IBD therapy withheld and rates of IBD flare post COVID-19.

TAKEAWAY:

• The likelihood of being treated for COVID-19 was higher in patients on corticosteroids (odds ratio [OR], 4.61; P = .002) or in those undergoing advanced IBD therapies (OR, 2.78; P = .041) prior to infection.
• Advanced age at the time of infection (adjusted OR [aOR], 1.06; P = .018) and corticosteroid treatment prior to contracting COVID-19 (aOR, 9.86; P = .001) were associated with an increased risk for severe infection.
• After adjustment for multiple factors, the likelihood of withholding IBD treatment was higher in patients being treated for COVID-19 (aOR, 6.95; P = .007).

IN PRACTICE:

“Patients with IBD on advanced therapies were frequently treated for acute COVID-19. Although COVID-19 treatment was associated with temporary withholding of IBD therapy, it did not result in increased IBD flares,” the authors wrote.

SOURCE:

The investigation, led by Laura C. Sahyoun, MD, Section of Digestive Diseases, Yale School of Medicine, New Haven, Connecticut, was published online in Digestive Diseases and Sciences.

LIMITATIONS:

Owing to the small sample size, the outcomes comparing antivirals to intravenous antibodies and SARS-CoV-2 strain prevalence could not be assessed. This single-center study also may not reflect the different clinical practices pertaining to IBD and COVID-19 treatments.

DISCLOSURES:

The study did not receive any specific funding. One author reported receiving speaker fees and being part of advisory boards, and another author received research support and reported being a part of advisory boards.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Treatment of patients with rheumatoid arthritis (RA) with non–tumor necrosis factor inhibitor (TNFi) biologic disease-modifying antirheumatic drugs (bDMARDs) may not pose an increased risk for cancer, compared with TNFis and conventional synthetic DMARDs.

METHODOLOGY:

• Previous research has presented conflicting results on the association between non-TNFi bDMARDs and the risk for cancer, with abatacept drawing particular attention owing to its mode of action.
• By utilizing information from Danish registers (January 2006-December 2020), researchers compared the risk for cancer in 14,944 patients with RA (age > 18 years) who were initiated on non-TNFi bDMARDs (tocilizumab/sarilumab, abatacept, or rituximab), TNFis, or were in the conventional synthetic DMARDs (bDMARD-naive) group.
• The patient population contributed to 21,982 treatment initiations, which corresponded to 1457, 1016, 690, 7458, and 11,361 treatment initiations for the tocilizumab/sarilumab, abatacept, rituximab, TNFi, and bDMARD-naive groups, respectively.
• Patients were followed up until a diagnosis was obtained for cancer, death, emigration, the initiation of a different bDMARD or a targeted synthetic DMARD, or the end of the study, whichever was earlier.
• The primary outcome was defined as any primary cancer diagnosis (except nonmelanoma skin cancer).

TAKEAWAY:

• The risk for overall cancer was not significantly higher in the tocilizumab/sarilumab-, abatacept-, or rituximab-initiated groups than in the TNFi-treated and bDMARD-naive groups.

• The likelihood of cancer appeared to be higher in patients with more than 5 years of exposure to abatacept than in the TNFi-treated (hazard ratio [HR], 1.41; 95% CI, 0.60-2.60) and bDMARD-naive groups (HR, 1.14; 95% CI, 0.51-2.33). However, the results were not statistically significant.
• Treatment with rituximab may be associated with a lower risk for hematologic cancers than for TNFi-treated (HR, 0.09; 95% CI, 0.00-2.06) or bDMARD-naive groups (HR, 0.13; 95% CI, 0.00-1.89), although the findings did not show statistical significance.

IN PRACTICE:

The authors wrote, “bDMARD-associated cancer risk remains a clinically important research question, and more future studies specifically investigating non-TNFi bDMARDs in terms of cancer risk in patients with RA are warranted.”

SOURCE:

The investigation, led by Rasmus Westermann, MD, of Aalborg University Hospital, Aalborg, Denmark, was published online on March 7 in Rheumatology.

LIMITATIONS:

Many patients received more than one type of non-TNFi bDMARD treatment during the study. Because the temporal relationship of DMARD treatment with cancer was not certain, potential carcinogenic treatment effects could not be distinguished. Limited data were available on cancer risk factors.

DISCLOSURES:

The study was supported by the Danish Rheumatism Association and the Danish Cancer Society. Some authors reported financial relationships with pharmaceutical companies outside of the submitted work.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Treatment of patients with rheumatoid arthritis (RA) with non–tumor necrosis factor inhibitor (TNFi) biologic disease-modifying antirheumatic drugs (bDMARDs) may not pose an increased risk for cancer, compared with TNFis and conventional synthetic DMARDs.

METHODOLOGY:

• Previous research has presented conflicting results on the association between non-TNFi bDMARDs and the risk for cancer, with abatacept drawing particular attention owing to its mode of action.
• By utilizing information from Danish registers (January 2006-December 2020), researchers compared the risk for cancer in 14,944 patients with RA (age > 18 years) who were initiated on non-TNFi bDMARDs (tocilizumab/sarilumab, abatacept, or rituximab), TNFis, or were in the conventional synthetic DMARDs (bDMARD-naive) group.
• The patient population contributed to 21,982 treatment initiations, which corresponded to 1457, 1016, 690, 7458, and 11,361 treatment initiations for the tocilizumab/sarilumab, abatacept, rituximab, TNFi, and bDMARD-naive groups, respectively.
• Patients were followed up until a diagnosis was obtained for cancer, death, emigration, the initiation of a different bDMARD or a targeted synthetic DMARD, or the end of the study, whichever was earlier.
• The primary outcome was defined as any primary cancer diagnosis (except nonmelanoma skin cancer).

TAKEAWAY:

• The risk for overall cancer was not significantly higher in the tocilizumab/sarilumab-, abatacept-, or rituximab-initiated groups than in the TNFi-treated and bDMARD-naive groups.

• The likelihood of cancer appeared to be higher in patients with more than 5 years of exposure to abatacept than in the TNFi-treated (hazard ratio [HR], 1.41; 95% CI, 0.60-2.60) and bDMARD-naive groups (HR, 1.14; 95% CI, 0.51-2.33). However, the results were not statistically significant.
• Treatment with rituximab may be associated with a lower risk for hematologic cancers than for TNFi-treated (HR, 0.09; 95% CI, 0.00-2.06) or bDMARD-naive groups (HR, 0.13; 95% CI, 0.00-1.89), although the findings did not show statistical significance.

IN PRACTICE:

The authors wrote, “bDMARD-associated cancer risk remains a clinically important research question, and more future studies specifically investigating non-TNFi bDMARDs in terms of cancer risk in patients with RA are warranted.”

SOURCE:

The investigation, led by Rasmus Westermann, MD, of Aalborg University Hospital, Aalborg, Denmark, was published online on March 7 in Rheumatology.

LIMITATIONS:

Many patients received more than one type of non-TNFi bDMARD treatment during the study. Because the temporal relationship of DMARD treatment with cancer was not certain, potential carcinogenic treatment effects could not be distinguished. Limited data were available on cancer risk factors.

DISCLOSURES:

The study was supported by the Danish Rheumatism Association and the Danish Cancer Society. Some authors reported financial relationships with pharmaceutical companies outside of the submitted work.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Treatment of patients with rheumatoid arthritis (RA) with non–tumor necrosis factor inhibitor (TNFi) biologic disease-modifying antirheumatic drugs (bDMARDs) may not pose an increased risk for cancer, compared with TNFis and conventional synthetic DMARDs.

METHODOLOGY:

• Previous research has presented conflicting results on the association between non-TNFi bDMARDs and the risk for cancer, with abatacept drawing particular attention owing to its mode of action.
• By utilizing information from Danish registers (January 2006-December 2020), researchers compared the risk for cancer in 14,944 patients with RA (age > 18 years) who were initiated on non-TNFi bDMARDs (tocilizumab/sarilumab, abatacept, or rituximab), TNFis, or were in the conventional synthetic DMARDs (bDMARD-naive) group.
• The patient population contributed to 21,982 treatment initiations, which corresponded to 1457, 1016, 690, 7458, and 11,361 treatment initiations for the tocilizumab/sarilumab, abatacept, rituximab, TNFi, and bDMARD-naive groups, respectively.
• Patients were followed up until a diagnosis was obtained for cancer, death, emigration, the initiation of a different bDMARD or a targeted synthetic DMARD, or the end of the study, whichever was earlier.
• The primary outcome was defined as any primary cancer diagnosis (except nonmelanoma skin cancer).

TAKEAWAY:

• The risk for overall cancer was not significantly higher in the tocilizumab/sarilumab-, abatacept-, or rituximab-initiated groups than in the TNFi-treated and bDMARD-naive groups.

• The likelihood of cancer appeared to be higher in patients with more than 5 years of exposure to abatacept than in the TNFi-treated (hazard ratio [HR], 1.41; 95% CI, 0.60-2.60) and bDMARD-naive groups (HR, 1.14; 95% CI, 0.51-2.33). However, the results were not statistically significant.
• Treatment with rituximab may be associated with a lower risk for hematologic cancers than for TNFi-treated (HR, 0.09; 95% CI, 0.00-2.06) or bDMARD-naive groups (HR, 0.13; 95% CI, 0.00-1.89), although the findings did not show statistical significance.

IN PRACTICE:

The authors wrote, “bDMARD-associated cancer risk remains a clinically important research question, and more future studies specifically investigating non-TNFi bDMARDs in terms of cancer risk in patients with RA are warranted.”

SOURCE:

The investigation, led by Rasmus Westermann, MD, of Aalborg University Hospital, Aalborg, Denmark, was published online on March 7 in Rheumatology.

LIMITATIONS:

Many patients received more than one type of non-TNFi bDMARD treatment during the study. Because the temporal relationship of DMARD treatment with cancer was not certain, potential carcinogenic treatment effects could not be distinguished. Limited data were available on cancer risk factors.

DISCLOSURES:

The study was supported by the Danish Rheumatism Association and the Danish Cancer Society. Some authors reported financial relationships with pharmaceutical companies outside of the submitted work.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Changes in plasma growth hormone mediators such as growth hormone receptor (GHR) and insulin-like growth factor-binding protein 1 (IGFBP-1) were associated with glycemic failure in youth-onset type 2 diabetes (T2D), an analysis of the TODAY trial showed.

METHODOLOGY:

• In youth, T2D often occurs during or after puberty, hinting at hormonal influences in the development and/or progression of the disease.
• This secondary analysis assessed the role of growth hormone mediators including insulin-like growth factor-1 (IGF-1), GHR, and IGFBP-1 in glycemic failure in a subset of 398 youths, aged 10-17 years, with a T2D duration of less than 2 years (62% girls; 21% White).
• The participants were followed up for a mean of 3.9 years.
• The primary outcomes included glycemic failure, defined as an A1c level of 8% or more for 6 months, or acute metabolic decompensation requiring insulin.
• Other assessments included baseline and 36-month measures of glycemia, insulin sensitivity, high molecular weight adiponectin, and beta cell function.

TAKEAWAY:

• Of 398 participants, 182 (46%) experienced glycemic failure, while 216 (54%) retained glycemic control.
• At 36 months, youths with glycemic failure had lower IGF-1 levels (P < .001) and higher log₂ GHR (P = .03) and log₂ IGFBP-1 (P = .009) levels than those who maintained glycemic control.
• A greater increase in IGF-1 level at 36 months was associated with lower odds of glycemic failure (odds ratio [OR], 0.995; P < .001).
• Increased levels of log₂ GHR and log₂ IGFBP-1 were associated with higher odds of glycemic failure (OR, 1.75; P = .04 and OR, 1.37; P = .007, respectively). Results were adjusted for body mass index (BMI), suggesting that associations between GHR level and glycemic outcomes exist independent of BMI.
• Interhormonal correlations suggested an association between glucose metabolism and growth hormone signaling or a shared process leading to changes in both processes.

IN PRACTICE:

“Our study has identified GHR level as a novel biomarker of decrease in glycemic control in youths with T2D,” the study authors wrote. Future research is needed, with an emphasis on assessing alterations in growth hormone mediators which may contribute to diabetes complications in youth.

SOURCE:

The study, published online in JAMA Network Open, was led by Chang Lu, MD, Division of Endocrinology, Boston Children’s Hospital, and Joslin Diabetes Center at Harvard Medical School, Boston, Massachusetts.

LIMITATIONS:

The study did not include a control group (individuals without diabetes). The cohort largely included youth in late puberty or after puberty, affecting subgroup analysis. Moreover, only circulating growth hormone mediators were measured, limiting the identity of the source tissue of the hormone and the target organs.

DISCLOSURES:

Some authors reported receiving grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases while conducting the study. Also, certain authors reported receiving grants and personal fees from various trusts as well as pharmaceutical, healthcare, and medical technology companies outside the submitted work.

TOPLINE:

Changes in plasma growth hormone mediators such as growth hormone receptor (GHR) and insulin-like growth factor-binding protein 1 (IGFBP-1) were associated with glycemic failure in youth-onset type 2 diabetes (T2D), an analysis of the TODAY trial showed.

METHODOLOGY:

• In youth, T2D often occurs during or after puberty, hinting at hormonal influences in the development and/or progression of the disease.
• This secondary analysis assessed the role of growth hormone mediators including insulin-like growth factor-1 (IGF-1), GHR, and IGFBP-1 in glycemic failure in a subset of 398 youths, aged 10-17 years, with a T2D duration of less than 2 years (62% girls; 21% White).
• The participants were followed up for a mean of 3.9 years.
• The primary outcomes included glycemic failure, defined as an A1c level of 8% or more for 6 months, or acute metabolic decompensation requiring insulin.
• Other assessments included baseline and 36-month measures of glycemia, insulin sensitivity, high molecular weight adiponectin, and beta cell function.

TAKEAWAY:

• Of 398 participants, 182 (46%) experienced glycemic failure, while 216 (54%) retained glycemic control.
• At 36 months, youths with glycemic failure had lower IGF-1 levels (P < .001) and higher log₂ GHR (P = .03) and log₂ IGFBP-1 (P = .009) levels than those who maintained glycemic control.
• A greater increase in IGF-1 level at 36 months was associated with lower odds of glycemic failure (odds ratio [OR], 0.995; P < .001).
• Increased levels of log₂ GHR and log₂ IGFBP-1 were associated with higher odds of glycemic failure (OR, 1.75; P = .04 and OR, 1.37; P = .007, respectively). Results were adjusted for body mass index (BMI), suggesting that associations between GHR level and glycemic outcomes exist independent of BMI.
• Interhormonal correlations suggested an association between glucose metabolism and growth hormone signaling or a shared process leading to changes in both processes.

IN PRACTICE:

“Our study has identified GHR level as a novel biomarker of decrease in glycemic control in youths with T2D,” the study authors wrote. Future research is needed, with an emphasis on assessing alterations in growth hormone mediators which may contribute to diabetes complications in youth.

SOURCE:

The study, published online in JAMA Network Open, was led by Chang Lu, MD, Division of Endocrinology, Boston Children’s Hospital, and Joslin Diabetes Center at Harvard Medical School, Boston, Massachusetts.

LIMITATIONS:

The study did not include a control group (individuals without diabetes). The cohort largely included youth in late puberty or after puberty, affecting subgroup analysis. Moreover, only circulating growth hormone mediators were measured, limiting the identity of the source tissue of the hormone and the target organs.

DISCLOSURES:

Some authors reported receiving grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases while conducting the study. Also, certain authors reported receiving grants and personal fees from various trusts as well as pharmaceutical, healthcare, and medical technology companies outside the submitted work.

TOPLINE:

Changes in plasma growth hormone mediators such as growth hormone receptor (GHR) and insulin-like growth factor-binding protein 1 (IGFBP-1) were associated with glycemic failure in youth-onset type 2 diabetes (T2D), an analysis of the TODAY trial showed.

METHODOLOGY:

• In youth, T2D often occurs during or after puberty, hinting at hormonal influences in the development and/or progression of the disease.
• This secondary analysis assessed the role of growth hormone mediators including insulin-like growth factor-1 (IGF-1), GHR, and IGFBP-1 in glycemic failure in a subset of 398 youths, aged 10-17 years, with a T2D duration of less than 2 years (62% girls; 21% White).
• The participants were followed up for a mean of 3.9 years.
• The primary outcomes included glycemic failure, defined as an A1c level of 8% or more for 6 months, or acute metabolic decompensation requiring insulin.
• Other assessments included baseline and 36-month measures of glycemia, insulin sensitivity, high molecular weight adiponectin, and beta cell function.

TAKEAWAY:

• Of 398 participants, 182 (46%) experienced glycemic failure, while 216 (54%) retained glycemic control.
• At 36 months, youths with glycemic failure had lower IGF-1 levels (P < .001) and higher log₂ GHR (P = .03) and log₂ IGFBP-1 (P = .009) levels than those who maintained glycemic control.
• A greater increase in IGF-1 level at 36 months was associated with lower odds of glycemic failure (odds ratio [OR], 0.995; P < .001).
• Increased levels of log₂ GHR and log₂ IGFBP-1 were associated with higher odds of glycemic failure (OR, 1.75; P = .04 and OR, 1.37; P = .007, respectively). Results were adjusted for body mass index (BMI), suggesting that associations between GHR level and glycemic outcomes exist independent of BMI.
• Interhormonal correlations suggested an association between glucose metabolism and growth hormone signaling or a shared process leading to changes in both processes.

IN PRACTICE:

“Our study has identified GHR level as a novel biomarker of decrease in glycemic control in youths with T2D,” the study authors wrote. Future research is needed, with an emphasis on assessing alterations in growth hormone mediators which may contribute to diabetes complications in youth.

SOURCE:

The study, published online in JAMA Network Open, was led by Chang Lu, MD, Division of Endocrinology, Boston Children’s Hospital, and Joslin Diabetes Center at Harvard Medical School, Boston, Massachusetts.

LIMITATIONS:

The study did not include a control group (individuals without diabetes). The cohort largely included youth in late puberty or after puberty, affecting subgroup analysis. Moreover, only circulating growth hormone mediators were measured, limiting the identity of the source tissue of the hormone and the target organs.

DISCLOSURES:

Some authors reported receiving grants from the National Institutes of Health and National Institute of Diabetes and Digestive and Kidney Diseases while conducting the study. Also, certain authors reported receiving grants and personal fees from various trusts as well as pharmaceutical, healthcare, and medical technology companies outside the submitted work.

TOPLINE:

The remission period of type 1 diabetes (T1D) can be prolonged with high-dose ergocalciferol (a vitamin D analog), by preserving the function of insulin-producing beta cells in newly diagnosed patients.

METHODOLOGY:

• Beta cells may retain approximately 30%-50% function at the time of T1D diagnosis and continue producing insulin for months or years. Preserving beta-cell function early on can extend this remission period and improve long-term glycemic control.
• Researchers conducted a secondary post hoc analysis of a randomized clinical trial looking at residual beta function and vitamin D supplementation in 36 youths (age, 10-21 years; mean age, 13.5 years; 33.3% women) with recently diagnosed T1D.
• Participants were randomly assigned to receive vitamin D (50,000 international units) or placebo every week for 2 months and then biweekly for 10 months.
• Mixed-meal tolerance tests were performed after overnight fasting at 0, 3, 6, 9, and 12 months, and blood draws were obtained 30 minutes and 90 minutes for post-meal C-peptide and glucose estimations.
• The fasting proinsulin to C-peptide ratio (PI:C) and the percentage change in the area under the curve of C-peptide from baseline (%ΔAUC) were calculated to test the effect of vitamin D on beta-cell function.

TAKEAWAY: 

• Vitamin D supplementation improved the insulin secretion capacity of beta cells, as observed by the decrease in the mean fasting PI:C ratio compared with placebo (−0.0009 vs 0.0011; P =.01).
• The reduction in %ΔAUC of C-peptide was notably slower with vitamin D than placebo (−2.8% vs −4.7%; P =.03), indicating a longer delay in the loss of C-peptide.

IN PRACTICE:

“It is exciting to know that vitamin D could protect the beta cells of the pancreas and increase the natural production of good and functional insulin in these patients. This, in turn, prolongs the honeymoon phase of type 1 diabetes and leads to reduced long-term complications of this disease,” Benjamin Udoka Nwosu, MD, Northwell Health, Division of Endocrinology, Department of Pediatrics, Cohen Children’s Medical Center, New Hyde Park, New York, the principal author, said in a press release.

SOURCE:

The study was published online in JAMA Network Open.

LIMITATIONS:

It was a single-center study.

DISCLOSURES:

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors did not report any conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

The remission period of type 1 diabetes (T1D) can be prolonged with high-dose ergocalciferol (a vitamin D analog), by preserving the function of insulin-producing beta cells in newly diagnosed patients.

METHODOLOGY:

• Beta cells may retain approximately 30%-50% function at the time of T1D diagnosis and continue producing insulin for months or years. Preserving beta-cell function early on can extend this remission period and improve long-term glycemic control.
• Researchers conducted a secondary post hoc analysis of a randomized clinical trial looking at residual beta function and vitamin D supplementation in 36 youths (age, 10-21 years; mean age, 13.5 years; 33.3% women) with recently diagnosed T1D.
• Participants were randomly assigned to receive vitamin D (50,000 international units) or placebo every week for 2 months and then biweekly for 10 months.
• Mixed-meal tolerance tests were performed after overnight fasting at 0, 3, 6, 9, and 12 months, and blood draws were obtained 30 minutes and 90 minutes for post-meal C-peptide and glucose estimations.
• The fasting proinsulin to C-peptide ratio (PI:C) and the percentage change in the area under the curve of C-peptide from baseline (%ΔAUC) were calculated to test the effect of vitamin D on beta-cell function.

TAKEAWAY: 

• Vitamin D supplementation improved the insulin secretion capacity of beta cells, as observed by the decrease in the mean fasting PI:C ratio compared with placebo (−0.0009 vs 0.0011; P =.01).
• The reduction in %ΔAUC of C-peptide was notably slower with vitamin D than placebo (−2.8% vs −4.7%; P =.03), indicating a longer delay in the loss of C-peptide.

IN PRACTICE:

“It is exciting to know that vitamin D could protect the beta cells of the pancreas and increase the natural production of good and functional insulin in these patients. This, in turn, prolongs the honeymoon phase of type 1 diabetes and leads to reduced long-term complications of this disease,” Benjamin Udoka Nwosu, MD, Northwell Health, Division of Endocrinology, Department of Pediatrics, Cohen Children’s Medical Center, New Hyde Park, New York, the principal author, said in a press release.

SOURCE:

The study was published online in JAMA Network Open.

LIMITATIONS:

It was a single-center study.

DISCLOSURES:

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors did not report any conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

The remission period of type 1 diabetes (T1D) can be prolonged with high-dose ergocalciferol (a vitamin D analog), by preserving the function of insulin-producing beta cells in newly diagnosed patients.

METHODOLOGY:

• Beta cells may retain approximately 30%-50% function at the time of T1D diagnosis and continue producing insulin for months or years. Preserving beta-cell function early on can extend this remission period and improve long-term glycemic control.
• Researchers conducted a secondary post hoc analysis of a randomized clinical trial looking at residual beta function and vitamin D supplementation in 36 youths (age, 10-21 years; mean age, 13.5 years; 33.3% women) with recently diagnosed T1D.
• Participants were randomly assigned to receive vitamin D (50,000 international units) or placebo every week for 2 months and then biweekly for 10 months.
• Mixed-meal tolerance tests were performed after overnight fasting at 0, 3, 6, 9, and 12 months, and blood draws were obtained 30 minutes and 90 minutes for post-meal C-peptide and glucose estimations.
• The fasting proinsulin to C-peptide ratio (PI:C) and the percentage change in the area under the curve of C-peptide from baseline (%ΔAUC) were calculated to test the effect of vitamin D on beta-cell function.

TAKEAWAY: 

• Vitamin D supplementation improved the insulin secretion capacity of beta cells, as observed by the decrease in the mean fasting PI:C ratio compared with placebo (−0.0009 vs 0.0011; P =.01).
• The reduction in %ΔAUC of C-peptide was notably slower with vitamin D than placebo (−2.8% vs −4.7%; P =.03), indicating a longer delay in the loss of C-peptide.

IN PRACTICE:

“It is exciting to know that vitamin D could protect the beta cells of the pancreas and increase the natural production of good and functional insulin in these patients. This, in turn, prolongs the honeymoon phase of type 1 diabetes and leads to reduced long-term complications of this disease,” Benjamin Udoka Nwosu, MD, Northwell Health, Division of Endocrinology, Department of Pediatrics, Cohen Children’s Medical Center, New Hyde Park, New York, the principal author, said in a press release.

SOURCE:

The study was published online in JAMA Network Open.

LIMITATIONS:

It was a single-center study.

DISCLOSURES:

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors did not report any conflicts of interest.

A version of this article appeared on Medscape.com.