Effects of Time-Restricted Eating on Weight Loss and Other Metabolic Parameters in Women and Men With Overweight and Obesity

Time-restricted eating, in the absence of other interventions, is not more effective in weight loss than eating throughout the day.

source: JAMA

Summary

Effects of Time-Restricted Eating on Weight Loss and Other Metabolic Parameters in Women and Men With Overweight and Obesity

The TREAT Randomized Clinical Trial

[Posted 14/Oct/2020]

AUDIENCE: Endocrinology, Internal Medicine

KEY FINDINGS: Time-restricted eating, in the absence of other interventions, is not more effective in weight loss than eating throughout the day.

BACKGROUND: The efficacy and safety of time-restricted eating have not been explored in large randomized clinical trials. Objective was to determine the effect of 16:8-hour time-restricted eating on weight loss and metabolic risk markers.

DETAILS: Participants were randomized such that the consistent meal timing (CMT) group was instructed to eat 3 structured meals per day, and the time-restricted eating (TRE) group was instructed to eat ad libitum from 12:00 pm until 8:00 pm and completely abstain from caloric intake from 8:00 pm until 12:00 pm the following day. This 12-week randomized clinical trial including men and women aged 18 to 64 years with a body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) of 27 to 43 was conducted on a custom mobile study application. Participants received a Bluetooth scale. Participants lived anywhere in the United States, with a subset of 50 participants living near San Francisco, California, who underwent in-person testing. The primary outcome was weight loss. Secondary outcomes from the in-person cohort included changes in weight, fat mass, lean mass, fasting insulin, fasting glucose, hemoglobin A1c levels, estimated energy intake, total energy expenditure, and resting energy expenditure. Overall, 116 participants (mean [SD] age, 46.5 [10.5] years; 70 [60.3%] men) were included in the study. There was a significant decrease in weight in the TRE (-0.94 kg; 95% CI, -1.68 to -0.20; P = .01), but no significant change in the CMT group (-0.68 kg; 95% CI, -1.41 to 0.05, P = .07) or between groups (-0.26 kg; 95% CI, -1.30 to 0.78; P = .63). In the in-person cohort (n = 25 TRE, n = 25 CMT), there was a significant within-group decrease in weight in the TRE group (-1.70 kg; 95% CI, -2.56 to -0.83; P < .001). There was also a significant difference in appendicular lean mass index between groups (-0.16 kg/m2; 95% CI, -0.27 to -0.05; P = .005). There were no significant changes in any of the other secondary outcomes within or between groups. There were no differences in estimated energy intake between groups.

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Source: Lowe, D. A., Wu, N., Rohdin-Bibby, L., Moore, A. H., Kelly, N., Liu, Y. E., … Weiss, E. J. (2020). Effects of Time-Restricted Eating on Weight Loss and Other Metabolic Parameters in Women and Men with Overweight and Obesity. JAMA Internal Medicine. https://doi.org/10.1001/jamainternmed.2020.4153

Published: September 2020


Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy

A once-weekly GLP-1RA was able to substitute for prandial insulin in 54% of people, substantially reducing the number of prandial insulin injections; glycemic control improved, with the added benefits of weight loss and less hypoglycemia in the GLP-1RA arm.

source: Diabetes Care

Summary

Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial

[Posted 19/Oct/2020]

AUDIENCE: Endocrinology, Internal Medicine

KEY FINDINGS: A once-weekly GLP-1RA was able to substitute for prandial insulin in 54% of people, substantially reducing the number of prandial insulin injections; glycemic control improved, with the added benefits of weight loss and less hypoglycemia in the GLP-1RA arm. Replacing prandial insulin with a weekly GLP-1RA can simplify basal plus prandial insulin treatments and achieve better outcomes in type 2 diabetes.

BACKGROUND: The principle of replacing prandial insulin lispro with a once-weekly glucagon-like peptide 1 receptor agonist (GLP-1RA) for type 2 diabetes inadequately controlled on a multiple daily insulin injections regimen was tested with albiglutide.

DETAILS: In this treat-to-target study, basal plus prandial insulin was optimized over 4 weeks before participants were randomized (1:1) to albiglutide plus optimized basal insulin glargine and lispro (dose reduced by 50% at randomization; subsequently, lispro injections were fully discontinued 4 weeks later) (n = 402) or to continued optimized lispro plus optimized glargine (n = 412). Mean ± SD HbA1c at baseline, 7.8 ± 0.6% (61 ± 7 mmol/mol) in the albiglutide + glargine group and 7.7 ± 0.6% (60 ± 7 mmol/mol) in the lispro + glargine group, was reduced at week 26 to 6.7 ± 0.8% (49 ± 8 mmol/mol) and 6.6 ± 0.8% (48 ± 8 mmol/mol), respectively (least squares [LS] difference 0.06% [95% CI -0.05 to 0.17]; noninferiority P < 0.0001). In the albiglutide + glargine group, 218 participants (54%) replaced all prandial insulin without reintroducing lispro up to week 26. Total daily prandial insulin dose was similar at baseline but was lower by 62 units/day (95% CI -65.9 to -57.8; P < 0.0001) at week 26 in the albiglutide + glargine group, and the total number of weekly injections was also reduced from 29 to 13 per week. Less severe/documented symptomatic hypoglycemia (57.2% vs. 75.0%) occurred in the albiglutide + glargine group with meaningful weight differences (LS mean ± SE -2.0 ± 0.2 vs. +2.4 ± 0.2 kg; P < 0.0001) vs. lispro + glargine. Gastrointestinal adverse events were higher with albiglutide + glargine (26% vs. 13%).

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Source: Rosenstock, J., Nino, A., Soffer, J., Erskine, L., Acusta, A., Dole, J., … Home, P. (2020). Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial. Diabetes Care, 43(10), dc192316. https://doi.org/10.2337/dc19-2316

Published: September 2020


Thyroid Replacement Therapy, Thyroid Stimulating Hormone Concentrations, and Long Term Health Outcomes in Patients With Hypothyroidism

In patients with a diagnosis of hypothyroidism, no evidence was found to suggest a clinically meaningful difference in the pattern of long term health outcomes (all cause mortality, atrial fibrillation, ischaemic heart disease, heart failure, stroke/transient ischaemic attack, fractures) when TSH concentrations were within recommended normal limits.

source: BMJ

Summary

Thyroid Replacement Therapy, Thyroid Stimulating Hormone Concentrations, and Long Term Health Outcomes in Patients With Hypothyroidism: Longitudinal Study

[Posted 09/Oct/2020]

AUDIENCE: Endocrinology, Internal Medicine

KEY FINDINGS: In patients with a diagnosis of hypothyroidism, no evidence was found to suggest a clinically meaningful difference in the pattern of long term health outcomes (all cause mortality, atrial fibrillation, ischemic heart disease, heart failure, stroke/transient ischemic attack, fractures) when TSH concentrations were within recommended normal limits. Evidence was found for adverse health outcomes when TSH concentration is outside this range, particularly above the upper reference value.

BACKGROUND: To explore whether thyroid stimulating hormone (TSH) concentration in patients with a diagnosis of hypothyroidism is associated with increased all cause mortality and a higher risk of cardiovascular disease and fractures.

DETAILS: Adult patients with incident hypothyroidism from 1 January 1995 to 31 December 2017 were enrolled. TSH concentration in patients with hypothyroidism were assessed. Main outcome measures were Ischemic heart disease, heart failure, stroke/transient ischemic attack, atrial fibrillation, any fractures, fragility fractures, and mortality. Longitudinal TSH measurements from diagnosis to outcomes, study end, or loss to follow-up were collected. An extended Cox proportional hazards model with TSH considered as a time varying covariate was fitted for each outcome. 162,369 patients with hypothyroidism and 863,072 TSH measurements were included in the analysis. Compared with the reference TSH category (2-2.5 mIU/L), risk of ischaemic heart disease and heart failure increased at high TSH concentrations (>10 mIU/L) (hazard ratio 1.18 (95% confidence interval 1.02 to 1.38; P=0.03) and 1.42 (1.21 to 1.67; P<0.001), respectively). A protective effect for heart failure was seen at low TSH concentrations (hazard ratio 0.79 (0.64 to 0.99; P=0.04) for TSH <0.1 mIU/L and 0.76 (0.62 to 0.92; P=0.006) for 0.1-0.4 mIU/L). Increased mortality was observed in both the lowest and highest TSH categories (hazard ratio 1.18 (1.08 to 1.28; P<0.001), 1.29 (1.22 to 1.36; P<0.001), and 2.21 (2.07 to 2.36; P<0.001) for TSH <0.1 mIU/L, 4-10 mIU/L, and >10 mIU/L. An increase in the risk of fragility fractures was observed in patients in the highest TSH category (>10 mIU/L) (hazard ratio 1.15 (1.01 to 1.31; P=0.03)).

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Source: Thayakaran, R., Adderley, N. J., Sainsbury, C., Torlinska, B., Boelaert, K., Šumilo, D., … Nirantharakumar, K. (2019). Thyroid replacement therapy, thyroid stimulating hormone concentrations, and long term health outcomes in patients with hypothyroidism: Longitudinal study. The BMJ, 366. https://doi.org/10.1136/bmj.l4892

Published: Aug 2020


Voluntary Recall: NDMA in Metformin

FDA is alerting patients and health care professionals to two voluntary recalls of extended release (ER) metformin by Marksans Pharma and Sun Pharmaceutical Industries.

source: FDA

Summary

FDA Updates and Press Announcements on NDMA in Metformin

[Posted 09/Oct/2020]

AUDIENCE: Endocrinology, Internal Medicine

10/5/2020: UPDATE – Marksans Pharma and Sun Pharmaceutical Industries voluntarily recall extended release (ER) metformin

FDA is alerting patients and health care professionals to two voluntary recalls of extended release (ER) metformin by Marksans Pharma and Sun Pharmaceutical Industries. The companies are recalling metformin because it may contain N-nitrosodimethylamine (NDMA) above the acceptable intake limit.

  • Marksans expanded its voluntary recall to include 76 additional unexpired lots of metformin ER tablets (500 mg and 750mg) labeled as Time-Cap Labs.
  • Sun voluntarily recalled one lot of Riomet ER, metformin hydrochloride for extended release oral suspension (500 mg per 5 mL).

FDA publishes a recalled metformin list including details about metformin products that have been recalled.

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Patients taking recalled ER metformin should continue taking it until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional. FDA recommends that health care professionals continue to prescribe metformin when clinically appropriate.

The agency’s testing has not shown NDMA in immediate release (IR) metformin products (the most commonly prescribed type of metformin).

Source: FDA

Published: October 05, 2020.


Omega-3, omega-6, and Total Dietary Polyunsaturated Fat for Prevention and Treatment of T2DM

This is the most extensive systematic review of trials to date to assess effects of polyunsaturated fats on newly diagnosed diabetes and glucose metabolism, including previously unpublished data following contact with authors. Evidence suggests that increasing omega-3, omega-6, or total PUFA has little or no effect on prevention and treatment of T2DM.

source: BMJ

Summary

Omega-3, Omega-6, and Total Dietary Polyunsaturated Fat for Prevention and Treatment of Type 2 Diabetes Mellitus: Systematic Review and Meta-Analysis of Randomised Controlled Trials

[Posted 02/Oct/2020]

AUDIENCE: Endocrinology, Internal Medicine

KEY FINDINGS: This is the most extensive systematic review of trials to date to assess effects of polyunsaturated fats on newly diagnosed diabetes and glucose metabolism, including previously unpublished data following contact with authors. Evidence suggests that increasing omega-3, omega-6, or total PUFA has little or no effect on prevention and treatment of type 2 diabetes mellitus.

BACKGROUND: To assess effects of increasing omega-3, omega-6, and total polyunsaturated fatty acids (PUFA) on diabetes diagnosis and glucose metabolism.

DETAILS: Data sources was Medline, Embase, Cochrane CENTRAL, WHO International Clinical Trials Registry Platform, Clinicaltrials.gov, and trials in relevant systematic reviews. Eligibility criteria were randomised controlled trials of at least 24 weeks’ duration assessing effects of increasing alpha-linolenic acid, long chain omega-3, omega-6, or total PUFA, which collected data on diabetes diagnoses, fasting glucose or insulin, glycated haemoglobin (HbA1c), and/or homoeostatic model assessment for insulin resistance (HOMA-IR). Statistical analysis included random effects meta-analyses using relative risk and mean difference, and sensitivity analyses. Funnel plots were examined and subgrouping assessed effects of intervention type, replacement, baseline risk of diabetes and use of antidiabetes drugs, trial duration, and dose. Risk of bias was assessed with the Cochrane tool and quality of evidence with GRADE. 83 randomised controlled trials (mainly assessing effects of supplementary long chain omega-3) were included; 10 were at low summary risk of bias. Long chain omega-3 had little or no effect on likelihood of diagnosis of diabetes (relative risk 1.00, 95% confidence interval 0.85 to 1.17; 58,643 participants, 3.7% developed diabetes) or measures of glucose metabolism (HbA1c mean difference -0.02%, 95% confidence interval -0.07% to 0.04%; plasma glucose 0.04, 0.02 to 0.07, mmol/L; fasting insulin 1.02, -4.34 to 6.37, pmol/L; HOMA-IR 0.06, -0.21 to 0.33). A suggestion of negative outcomes was observed when dose of supplemental long chain omega-3 was above 4.4 g/d. Effects of alpha-linolenic acid, omega-6, and total PUFA on diagnosis of diabetes were unclear (as the evidence was of very low quality), but little or no effect on measures of glucose metabolism was seen, except that increasing alpha-linolenic acid may increase fasting insulin (by about 7%). No evidence was found that the omega-3/omega-6 ratio is important for diabetes or glucose metabolism.

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Source: Brown, T. J., Brainard, J., Song, F., Wang, X., Abdelhamid, A., & Hooper, L. (2019). Omega-3, omega-6, and total dietary polyunsaturated fat for prevention and treatment of type 2 diabetes mellitus: Systematic review and meta-analysis of randomised controlled trials. The BMJ, 366. https://doi.org/10.1136/bmj.l4697

Published: Aug 2020


Glucocorticoid Dose-Dependent Risk of T2D in Six Immune-Mediated Inflammatory Diseases

Dose-dependent risks of type 2 diabetes associated with glucocorticoid use for six common immune-mediated inflammatory diseases. These results underline the need for regular diabetic risk assessment and testing during glucocorticoid therapy in these patients.

source: BMJ DRC

Summary

Glucocorticoid Dose-Dependent Risk of Type 2 Diabetes in Six Immune-Mediated Inflammatory Diseases: A Population-Based Cohort Analysis

[Posted 29/Sep/2020]

AUDIENCE: Endocrinology, Internal Medicine

KEY FINDINGS: Dose-dependent risks of type 2 diabetes associated with glucocorticoid use for six common immune-mediated inflammatory diseases. These results underline the need for regular diabetic risk assessment and testing during glucocorticoid therapy in these patients.

BACKGROUND: In immune-mediated inflammatory diseases, there is a lack of -estimates of glucocorticoid dose-response diabetes risk that consider changes in prescribed dose over time and disease activity.

DETAILS: Population-based longitudinal analysis of electronic health records from the UK Clinical Practice Research Datalink, linked to hospital admissions and the mortality registry (1998-2017). We included 100 722 adult patients without diabetes history, diagnosed with giant cell arteritis or polymyalgia rheumatica (n=32 593), inflammatory bowel disease (n=29 272), rheumatoid arthritis (n=28 365), vasculitis (n=6082), or systemic lupus erythematosus (n=4410). We estimated risks and HRs of type 2 diabetes associated with time-variant daily and total cumulative prednisolone-equivalent glucocorticoid dose using Cox regression methods. Average patient age was 58.6 years, 65 469 (65.0%) were women and 8858 (22.6%) had a body mass index (BMI) >=30 kg/m2. Overall, 8137 (8.1%) people developed type 2 diabetes after a median follow-up of 4.9 years. At 1 year, the cumulative risk of diabetes increased from 0.9% during periods of non-use to 5.0% when the daily prednisolone-equivalent dose was >=25.0 mg. We found strong dose-dependent associations for all immune-mediated diseases, BMI levels and underlying disease duration, even after controlling for periods of active systemic inflammation. Adjusted HR for a <5.0 mg daily dose versus non-use was 1.90, 95% CI 1.44 to 2.50; range 1.70 for rheumatoid arthritis to 2.93 for inflammatory bowel disease.

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Source: Wu, J., Mackie, S. L., & Pujades-Rodriguez, M. (2020). Glucocorticoid dose-dependent risk of type 2 diabetes in six immune-mediated inflammatory diseases: a population-based cohort analysis. BMJ Open Diabetes Research & Care, 8(1), e001220. https://doi.org/10.1136/bmjdrc-2020-001220

Published: Aug 2020


Cardiovascular Outcomes of T2D Patients Treated with SGLT-2 Inhibitors Versus GLP-1 Receptor Agonists In Real-Life

In the absence of dedicated trials, this observational study suggests that SGLT2i may be more effective than GLP-1RA in improving cardiovascular outcomes of T2D.

source: BMJ DRC

Summary

Cardiovascular Outcomes of Type 2 DiabeticPatients Treated with SGLT-2 Inhibitors Versus GLP-1 Receptor Agonists in Real-Life

[Posted 24/Sep/2020]

AUDIENCE: Endocrinology, Cardiology, Internal Medicine

KEY FINDINGS: In the absence of dedicated trials, this observational study suggests that SGLT2i may be more effective than GLP-1RA in improving cardiovascular outcomes of T2D.

BACKGROUND: Sodium glucose cotransporter-2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA) protect type 2 diabetic (T2D) patients from cardiovascular events, but no trial has directly compared their cardiovascular effects. We aimed to address this gap using real-world data.

DETAILS: A retrospective real-world study on a population of ~5 million inhabitants from North-East Italy was conducted. T2D patients who received new prescription of SGLT2i or GLP-1RA from 2014 to 2018 were identified. SGLT2i and GLP-1RA initiators were matched 1:1 by propensity scores. The primary outcome was a composite of all-cause death, myocardial infarction, and stroke (three-point major adverse cardiovascular events (3P-MACE)). Secondary endpoints were each component of the primary endpoint, hospitalization for heart failure (HF), revascularization, hospitalization for cardiovascular causes, and adverse events. From a population of 330 193 diabetic patients, we followed 8596 SGLT2i and GLP-1RA matched initiators for a median of 13 months. Patients in both groups were on average 63 years old, 63% men, and 18% had pre-existing cardiovascular disease. T2D patients treated with SGLT2i versus GLP-1RA, experienced a lower rate of 3P-MACE (HR 0.68; 95% CI 0.61 to 0.99; p=0.043), myocardial infarction (HR 0.72; 95% CI 0.53 to 0.98; p=0.035), hospitalization for HF (HR 0.59; 95% CI 0.35 to 0.99; p=0.048), and hospitalization for cardiovascular causes (HR 0.82; 95% CI 0.69 to 0.99; p=0.037). Adverse events were not significantly different between the two groups.

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Source: Longato, E., Di Camillo, B., Sparacino, G., Gubian, L., Avogaro, A., & Fadini, G. P. (2020). Cardiovascular outcomes of type 2 diabetic patients treated with SGLT-2 inhibitors versus GLP-1 receptor agonists in real-life. BMJ Open Diabetes Research & Care, 8(1), 1451. https://doi.org/10.1136/bmjdrc-2020-001451

Published: August 2020


Insulin Sensitizers for Improving the Endocrine and Metabolic Profile in Overweight Women With PCOS

For overweight women with PCOS, both metformin combined with GLP-1 receptor agonists and metformin combined with TZDs appear superior to monotherapy in improving hyperandrogenemia. Metformin combined with TZDs could be particularly effective in promoting the recovery of menstruation.

source: JCEM

Summary

Insulin Sensitizers for Improving the Endocrine and Metabolic Profile in Overweight Women With PCOS

[Posted 16/Sep/2020]

AUDIENCE: Endocrinology, Ob/Gyn, Internal Medicine

KEY FINDINGS: For overweight women with PCOS, both metformin combined with GLP-1 receptor agonists and metformin combined with TZDs appear superior to monotherapy in improving hyperandrogenemia. Metformin combined with TZDs could be particularly effective in promoting the recovery of menstruation. Metformin combined with GLP-1 receptor agonists has the additional advantage of improving fasting glucose when compared with GLP-1 receptor agonists alone. TZDs are inferior to metformin in decreasing BMI.

BACKGROUND: To evaluate the efficacy of insulin sensitizers on menstrual frequency, sex hormone, and metabolic parameters in overweight women with polycystic ovary syndrome (PCOS).

DETAILS: Multiple databases from inception to September 2019 for randomized controlled trials were searched. Network meta-analysis was conducted using multivariate random effects method. Fourteen trials reporting on 619 women were included. Compared with metformin, metformin + thiazolidinediones (TZDs) was more superior in menstrual recovery (weighted mean difference [WMD] 3.68; 95% credibility interval [CrI], 1.65 to 8.20), metformin + glucagon-like peptide-1 (GLP-1) receptor agonists was more effective in decreasing androstenedione (WMD -2.53; 95% CrI, -3.96 to -1.09), both metformin + GLP-1 receptor agonists (WMD 9.22; 95% CrI, 5.46 to 12.98) and metformin + TZDs (WMD 4.30; 95% CrI, 0.78 to 7.82) were more effective in increasing sex hormone–binding globulin (SHBG), while TZDs were less effective in decreasing body mass index (BMI) (WMD 1.69; 95% CrI, 0.72 to 2.66). Compared with GLP-1 receptor agonists, metformin + GLP-1 receptor agonists was associated with higher SHBG (WMD 7.80; 95% CrI, 4.75 to 10.85), lower free testosterone (WMD -1.77; 95% CrI, -3.25 to -0.29), lower androstenedione (WMD -2.70; 95% CrI, -3.91 to -1.50) and lower fasting blood glucose (WMD -0.41; 95% CrI, -0.73 to -0.08).

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Source: Chuan Xing, Chunzhu Li, Bing He, Insulin Sensitizers for Improving the Endocrine and Metabolic Profile in Overweight Women With PCOS, The Journal of Clinical Endocrinology & Metabolism, Volume 105, Issue 9, September 2020, dgaa337, https://doi.org/10.1210/clinem/dgaa337

Published: July 2020


Continuous Positive Airway Pressure Treatment, Glycemia, and Diabetes Risk in Obstructive Sleep Apnea and Comorbid Cardiovascular Disease

Among patients with established CVD and OSA no evidence found that CPAP therapy over several years affects glycemic control in those with diabetes or prediabetes or diabetes risk over standard-of-care treatment.

source: Diabetes Care

Summary

Continuous Positive Airway Pressure Treatment, Glycemia, and Diabetes Risk in Obstructive Sleep Apnea and Comorbid Cardiovascular Disease

[Posted 08/Sep/2020]

AUDIENCE: Endocrinology, Pediatric, Internal Medicine, Nephrology

KEY FINDINGS: Among patients with established CVD and OSA no evidence found that CPAP therapy over several years affects glycemic control in those with diabetes or prediabetes or diabetes risk over standard-of-care treatment. The potential differential effect according to sex deserves further investigation.

BACKGROUND: Despite evidence of a relationship among obstructive sleep apnea (OSA), metabolic dysregulation, and diabetes, it is uncertain whether OSA treatment can improve metabolic parameters. We sought to determine effects of long-term continuous positive airway pressure (CPAP) treatment on glycemic control and diabetes risk in patients with cardiovascular disease (CVD) and OSA.

DETAILS: Blood, medical history, and personal data were collected in a substudy of 888 participants in the Sleep Apnea cardioVascular Endpoints (SAVE) trial in which patients with OSA and stable CVD were randomized to receive CPAP plus usual care, or usual care alone. Serum glucose and glycated hemoglobin A1c (HbA1c) were measured at baseline, 6 months, and 2 and 4 years and incident diabetes diagnoses recorded. Median follow-up was 4.3 years. In those with preexisting diabetes (n = 274), there was no significant difference between the CPAP and usual care groups in serum glucose, HbA1c, or antidiabetic medications during follow-up. There were also no significant between-group differences in participants with prediabetes (n = 452) or new diagnoses of diabetes. Interaction testing suggested that women with diabetes did poorly in the usual care group, while their counterparts on CPAP therapy remained stable.

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Source: Loffler, K. A., Heeley, E., Freed, R., Meng, R., Bittencourt, L. R., Gonzaga Carvalho, C. C., … Drager, L. F. (2020). Continuous Positive Airway Pressure Treatment, Glycemia, and Diabetes Risk in Obstructive Sleep Apnea and Comorbid Cardiovascular Disease. Diabetes Care, 43(8), dc192006. https://doi.org/10.2337/dc19-2006

Published: July 2020


FDA Approves First-of-its-Kind Automated Insulin Delivery and Monitoring System for Use in Young Pediatric Patients

FDA approved the MiniMed 770G System, a hybrid closed loop diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input from the users or their caregivers for use by individuals aged 2 to 6 with T1D.

source: FDA

Summary

FDA Approves First-of-its-Kind Automated Insulin Delivery and Monitoring System for Use in Young Pediatric Patients

[Posted 02/Sep/2020]

AUDIENCE: Endocrinology, Pediatric, Internal Medicine, Nephrology

Today, the U.S. Food and Drug Administration approved the MiniMed 770G System, a hybrid closed loop diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input from the users or their caregivers for use by individuals aged 2 to 6 with type 1 diabetes. The 770G System is a first-of-a-kind device for patients aged 2 to 6 years. It is the first legally marketed device that can automatically adjust insulin delivery based on continuous glucose monitor values for this patient population.

“Advancements in science, technology and manufacturing have helped make great strides in the treatment and successful management of type 1 diabetes, a life-threatening chronic condition,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA is dedicated to promoting policies that support the development of new technologies based on these advances, and remains committed to helping ensure that development and expansion of products that can improve the quality of life for those with this condition—which can particularly impact children—is safe and effective.”

Patients with Type 1 diabetes, or their caregivers, must consistently monitor their glucose levels throughout the day and inject insulin with a syringe, pen or pump to maintain adequate glucose levels in order to avoid becoming hyperglycemic (high glucose levels) or hypoglycemic (low glucose levels).

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The MiniMed 770G System, a bluetooth-enabled version of the previously approved MiniMed 670G System (with other modifications), is a hybrid closed loop system that works by measuring glucose levels in the body every five minutes and automatically adjusting insulin delivery by either administering or withholding insulin. The system includes: a sensor that attaches to the body to measure glucose levels under the skin; an insulin pump strapped to the body; and an infusion patch connected to the pump with a catheter that delivers insulin. While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate consumption at mealtime.

The FDA evaluated data from a clinical trial that included 46 children aged 2 to 6 years old with type 1 diabetes. Study participants wore the device for approximately three months to evaluate the performance of the device during both the at-home periods, as well as a hotel period, to stress the system with sustained daily exercise. That study found no serious adverse events and that the device is safe for use. Data from that study was used to help support the expanded indication for patients 2 to 6 years old.

Risks associated with use of the system may include hypoglycemia, hyperglycemia, as well as skin irritation or redness around the device’s infusion patch. As part of this approval, the FDA is requiring the device manufacturer to conduct a post-market study to evaluate device performance in real-world settings in children between the ages of 2 and 6.

This device is not approved for use in children younger than 2 years old and in individuals who require less than eight units of insulin per day.

The approval of the MiniMed 770G hybrid closed loop system was granted to Medtronic.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Source: FDA

Published: August 31, 2020.


Vitamin D and OmegA-3 TriaL (VITAL): Effects of Vitamin D Supplements on Risk of Falls in the US Population

Daily supplemental vitamin D3 vs placebo did not decrease fall risk in generally healthy adults not selected for vitamin D insufficiency. This large RCT does not indicate that supplemental vitamin D should be used for primary prevention of falls in the US population.

source: JCEM

Summary

Vitamin D and OmegA-3 TriaL (VITAL): Effects of Vitamin D Supplements on Risk of Falls in the US Population

[Posted 24/Aug/2020]

AUDIENCE: Endocrinology, Family Medicine, Internal Medicine

KEY FINDINGS: Daily supplemental vitamin D3 vs placebo did not decrease fall risk in generally healthy adults not selected for vitamin D insufficiency. This large RCT does not indicate that supplemental vitamin D should be used for primary prevention of falls in the US population.

BACKGROUND: It is unclear whether vitamin D supplementation reduces risk of falls, and results from randomized controlled trials (RCTs) are conflicting. The objective of this work is to determine whether 2000 IU/day of supplemental vitamin D3 decreases fall risk.

DETAILS: Vitamin D and OmegA-3 Trial (VITAL) is a double-blind, placebo-controlled RCT including 25 871 adults, randomly assigned November 2011 to March 2014 and treated for 5.3 years (median). Men 50 years or older and women 55 years or older (mean age, 67.1 years) without cancer or cardiovascular disease at baseline participated in this study. Interventions included vitamin D3 (cholecalciferol; 2000 IU/day) and/or omega-3 fatty acids (1 g/day) or respective placebos in a 2 × 2 factorial design. Main outcome measures include 2 or more falls and falls resulting in a doctor or hospital visit. Baseline serum total 25-hydroxyvitamin D (25[OH]D) level was 77 nmol/L; characteristics were well-balanced between groups. Numbers of participants with 2 or more falls were similar between active and placebo groups (9.8% vs 9.4%). Over 5 years, there were no differences in the proportion having 2 or more falls (odds ratio [OR] = 0.97; 95% CI, 0.90-1.05, P = .50), falls resulting in a doctor visit (OR = 1.03; 95% CI, 0.94-1.13, P = .46), or resulting in a hospital visit (OR = 1.04; 95% CI, 0.90-1.19, P = .61) between groups. Results did not differ between those with baseline 25(OH)D less than 50 vs 50 nmol/L or greater or other cut points.

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ABC of Diabetes
EBMG: Diabetes and Endocrinology

Source: Meryl S LeBoff, Elle M Murata, Nancy R Cook, Peggy Cawthon, Sharon H Chou, Gregory Kotler, Vadim Bubes, Julie E Buring, JoAnn E Manson, VITamin D and OmegA-3 TriaL (VITAL): Effects of Vitamin D Supplements on Risk of Falls in the US Population, The Journal of Clinical Endocrinology & Metabolism, Volume 105, Issue 9, September 2020, dgaa311, https://doi.org/10.1210/clinem/dgaa311

Published: July 2020


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