Use of Placebo in Supplementation Studies-Vitamin D Research Illustrates an Ethical Quandary.

History has shown that without explicit and enforced guidelines, even well-intentioned researchers can fail to adequately examine the ethical pros and cons of study design choices. One area in which consensus does not yet exist is the use of placebo groups in vitamin supplementation studies. As a prime example, we focus on vitamin D research. We aim to provide an overview of the ethical issues in placebo-controlled studies and guide future discussion about the ethical use of placebo groups. Research in the field of vitamin D shows variation in how placebo groups are used. We outline four types of control groups in use: active-control, placebo-control with restrictions on supplementation, placebo-control without supplementation restrictions, and placebo-control with rescue repletion therapy. The first two types highlight discrete ethical issues: active-control trials limit the ability to detect a difference; placebo-control trials that restrict supplementation potentially place subjects at risk of undue harm. The final two, placebo-control without supplementation restrictions or with rescue repletion therapy, offer potential solutions to these ethical challenges. Building on this, guidelines should be established and enforced on the use of placebo in supplementation studies. Furthermore, the field of vitamin D research has the potential to set an example worthy of emulation

A Clinical Score to Predict Dose Reductions of Antidiabetes Medications with Intentional Weight Loss: A Retrospective Cohort Study.

Abstract Background We assessed the predictive accuracy of an empirically-derived score (weight loss, insulin resistance, and glycemic control: “WIG”) to predict patients who will be successful in reducing diabetes mellitus (DM) medication use with weight loss. Methods Case records of 121 overweight and obese patients with DM at two outpatient weight management centers were analyzed. Results Mean period of follow-up was 12.5 ± 3.5 months. To derive the “WIG” scoring algorithm, one point each was assigned to “W” (loss of 5% of initial body weight within the first 3 months of attempting weight loss), “I” (triglyceride [TGL]/highdensity lipoprotein ratio \u3e3 [marker of insulin resistance] at baseline), and “G” (glycosylated hemoglobin [A1c%] \u3e8.5 at baseline). WIG score showed moderate accuracy in discriminating anti-DM dose reductions at baseline, and after 3 months of weight loss efforts (likelihood ratios [LR] + \u3e1, LR−0.7), and demonstrated good reproducibility. Conclusions WIG score shows promise as a tool to predict success with dose reductions of antidiabetes medications. Keywords Clinical score; Diabetes mellitus; Insulin resistance; Obesit

Intentional weight loss and dose reductions of anti-diabtetic medications: A retrospective cohort study

Background and Aim Intentional weight loss, primarily by improving insulin resistance, is known to decrease the need for anti-diabetic medications. In this study, we assess the magnitude of weight loss that resulted in dose reductions or discontinuation of anti-diabetic medications in overweight or obese patients with type 2 diabetes (DM) undergoing weight loss treatment. Methods Case records of 50 overweight or obese patients with DM who successfully decreased dosage or discontinued diabetes medications after losing weight via attendance at two University-based, outpatient weight management centers were analyzed. Follow-up visits, weight reduction interventions, and decisions for dose reductions or discontinuation of medications were individualized to patient needs by the treating physician. Results Mean starting BMI was 35 kg/m2, mean age 53.4 years, and 58% were male. All 50 used at least one anti-diabetic medication (30 metformin, 39 sulfonylureas, 31 insulin, 21 sitagliptin) to manage blood sugar. Mean duration of follow-up was 30.2 months. Mean weight loss was 10.8±4.1 kgs (11.1% of initial body weight ±4.7%). 22/50 patients (44%) discontinued anti-diabetes medications (14 sulfonylureas [36%], 7 insulin [23%], 4 sitagliptin [19%]). The mean percentage weight loss achieved at the point of successful discontinuation of medication was 11.2%±3.5% (14% for sulphonylureas, 11% for insulin, and 7.1% for sitagliptin). Mean percentage weight loss of 5.6%±2.8% (5.1% for sulphonylureas, 4.3% for insulin, and 7.1% for sitagliptin) was required for initial dose reduction. For every 5% weight loss, predicted dose reductions were sulphonylureas, 39%; insulin, 42%; and any anti-diabetic medications, 49%. Conclusion Among overweight or obese patients with type 2 diabetes, intentional weight loss of 7–14% was typically required for full discontinuation of at least one anti-diabetic medication. Discontinuation of insulin was achieved at a mean weight reduction of 11% of initial body weight

Prevalence, Management, and Associated Factors of Obesity, Hypertension, and Diabetes in Tibetan Population Compared with China Overall

Tibetans’ life expectancy lags behind China’s average. Obesity and noncommunicable diseases (NCDs) contribute to health disparity, but NCD patterns among Tibetans are unknown. To examine the prevalence, management, and associated factors for obesity, hypertension, and diabetes among Tibetans, compared with China’s average, we systematically searched PubMed and China National Knowledge Infrastructure databases for studies between January 2010 and April 2021. Thirty-nine studies were included for systematic review, among thirty-seven that qualified for meta-analysis, with 115,403 participants. Pooled prevalence was 47.9% (95% CI 38.0–57.8) for overweight/obesity among adults (BMI ≥ 24 kg/m2) and 15.4% (13.7–17.2) among children using Chinese criteria, which are lower than the national rates of 51.2% and 19.0%, respectively. The estimate for hypertension (31.4% [27.1–35.7]) exceeded China’s average (27.5%), while diabetes (7.5% [5.2–9.8]) was lower than average (11.9%). Men had a higher prevalence of the three conditions than women. Residents in urban areas, rural areas, and Buddhist institutes had monotonically decreased prevalence in hypertension and diabetes. Awareness, treatment, and control rates for hypertension and diabetes were lower than China’s average. Urban residence and high altitude were consistent risk factors for hypertension. Limited studies investigated factors for diabetes, yet none exist for obesity. Tibetans have high burdens of obesity and hypertension. Representative and longitudinal studies are needed for tailored interventions. There are considerable variations in study design, study sample selection, and data-analysis methods, as well as estimates of reviewed studies.This work was supported by the National Key Research & Development Program of China [grant numbers 2017YFC0907200 & 2017YFC0907201]; the Natural Scientific Foundation of China [grant number 82103846]; and the Chinese Nutrition Society [grant number CNS-SCP-2020-40]

Differences in health-related behaviors between middle school, high school, and college students in Jiangsu province, China

BACKGROUND AND OBJECTIVES: Increasing rates of obesity among Chinese adolescents has become a major public health concern in recent years. Studies have shown that factors such as food choices, physical activity, and screen time play important roles in fostering obesity. We examined a number of biological and social determinants that influence these factors. To determine whether dietary behavior, physical activity, and screen time varied among students in different stages of their education. METHODS AND STUDY DESIGN: Students in 13 cities across Jiangsu Province completed an anonymous survey assessing demographics and various health-related behaviors in a controlled setting. The survey population ranged from middle school students to undergraduates. 55,361 surveys were returned, and 46,611 (84.2%) were usable for the analysis. Multiple linear regression models were used to investigate the relationship between four behavioral factors (dietary behavior, screen time, physical activity, and moderate exercise) and seven predictors (gender, age, BMI, mother's education, nearsightedness, allowance, and geographic region). RESULTS: Baseline characteristics of the survey population analyzed by education level (middle school, high school, college and beyond) showed moderate differences in demographics among the three groups. Physical activity, moderate exercise, and dietary behavior decreased with educational level, while screen time increased. All predictors in the four considered regression models were statistically significant. CONCLUSIONS: This unique, large-scale survey of Chinese students in a region of contrasting economic development revealed numerous relationships between health-related diet and physical-activity, region, and education level. These findings can inform the development of measures to counteract the rise of obesity in China

Intentional Weight Loss and Dose Reductions of Anti-Diabetic Medications – A Retrospective Cohort Study

BACKGROUND AND AIM: Intentional weight loss, primarily by improving insulin resistance, is known to decrease the need for anti-diabetic medications. In this study, we assess the magnitude of weight loss that resulted in dose reductions or discontinuation of anti-diabetic medications in overweight or obese patients with type 2 diabetes (DM) undergoing weight loss treatment. METHODS: Case records of 50 overweight or obese patients with DM who successfully decreased dosage or discontinued diabetes medications after losing weight via attendance at two University-based, outpatient weight management centers were analyzed. Follow-up visits, weight reduction interventions, and decisions for dose reductions or discontinuation of medications were individualized to patient needs by the treating physician. RESULTS: Mean starting BMI was 35 kg/m(2), mean age 53.4 years, and 58% were male. All 50 used at least one anti-diabetic medication (30 metformin, 39 sulfonylureas, 31 insulin, 21 sitagliptin) to manage blood sugar. Mean duration of follow-up was 30.2 months. Mean weight loss was 10.8 ± 4.1 kgs (11.1% of initial body weight ± 4.7%). 22/50 patients (44%) discontinued anti-diabetes medications (14 sulfonylureas [36%], 7 insulin [23%], 4 sitagliptin [19%]). The mean percentage weight loss achieved at the point of successful discontinuation of medication was 11.2% ± 3.5% (14% for sulphonylureas, 11% for insulin, and 7.1% for sitagliptin). Mean percentage weight loss of 5.6% ± 2.8% (5.1% for sulphonylureas, 4.3% for insulin, and 7.1% for sitagliptin) was required for initial dose reduction. For every 5% weight loss, predicted dose reductions were sulphonylureas, 39%; insulin, 42%; and any anti-diabetic medications, 49%. CONCLUSION: Among overweight or obese patients with type 2 diabetes, intentional weight loss of 7-14% was typically required for full discontinuation of at least one anti-diabetic medication. Discontinuation of insulin was achieved at a mean weight reduction of 11% of initial body weight

Triglyceride/HDL ratio as a screening tool for predicting success at reducing anti-diabetic medications following weight loss.

PMC3712020BACKGROUND AND OBJECTIVES: Intentional weight loss, by reducing insulin resistance, results in both better glycemic control and decreased need for anti-diabetic medications. However, not everyone who is successful with weight loss is able to reduce anti-diabetic medication use. In this retrospective cohort study, we assessed the predictive accuracy of baseline triglyceride (TGL)/HDL ratio, a marker of insulin resistance, to screen patients for success in reducing anti-diabetic medication use with weight loss. METHODS: Case records of 121 overweight and obese attendees at two outpatient weight management centers were analyzed. The weight loss intervention consisted of a calorie-restricted diet (~1000Kcal/day deficit), a behavior modification plan, and a plan for increasing physical activity. RESULTS: Mean period of follow-up was 12.5 ± 3.5 months. By study exit, mean weight loss and mean HbA1c% reduction were 15.4 ± 5.5 kgs and 0.5 ± 0.2% respectively. 81 (67%) in the study cohort achieved at least 1 dose reduction of any anti-diabetic medication. Tests for predictive accuracy of baseline TGL/HDL ratio ≤ 3 to determine success with dose reductions of anti-diabetic medications showed a sensitivity, specificity, positive predictive value, negative predictive value, area under the curve, likelihood ratio (LR) + and LR-of 81, 83, 90, 70, 78, 4.8 and 0.2, respectively. Reproducibility of TGL/HDL ratio was acceptable. CONCLUSION: TGL/HDL ratio shows promise as an effective screening tool to determine success with dose reductions of anti-diabetic medications. The results of our study may inform the conduct of a systematic review using data from prior weight loss trials.JH Libraries Open Access Fun

Partial Meal Replacement Plan and Quality of the Diet at 1 Year: Action for Health in Diabetes (Look AHEAD) Trial

Little is known about diet quality with a reduced-energy, low-fat, partial meal replacement (PMR) plan, especially in individuals with type 2 diabetes. The Action for Health in Diabetes (Look AHEAD) trial implemented a PMR plan in the intensive lifestyle intervention (ILI)