A Pilot Study Evaluating the Effects of Diabetes Specific Nutrition Supplement and Lifestyle Intervention on Glycemic Control in Overweight and Obese Asian Indian Adults with Type 2 Diabetes Mellitus

Abstract

Medical nutrition therapy plays a crucial role achievement of optimal glycemic control in individuals with diabetes. This study aims to evaluate the effects of diabetes specific nutrition supplement (DSNS) along with lifestyle intervention in overweight and obese adults with Type 2 Diabetes Mellitus (T2DM). METHODS: A total of 120 overweight or obese individuals aged 30 - 65 years with T2DM, were randomly allocated to intervention (IG, n=60) and control (CG, n=60) groups in this 12-week study. All participants received dietary counselling with diet chart of 1400 kcal/day and recommendations for physical activity. DSNS was included in the dietary regimen adjusted within the daily calorie recommendations for intervention group. All participants were followed up monthly for anthropometric, biochemical and clinical assessments. Continuous glucose monitoring was performed during the initial 2 weeks and last 2 weeks of the study in a sub- sample using Flash Glucose Monitoring device to study glycemic excursions. Data was analyzed for the differences between intervention vs. control group using linear models. RESULTS: Compared to the control group, the intervention group showed significant reduction in glycosylated haemoglobin (IG: -0.95% vs. CG: -0.48%; p=0.020) and fasting blood glucose (IG: -18.47 mg/dL vs. CG: 1.34mg/dL; p=0.03) as well as a greater reduction in postprandial plasma glucose (IG: -29.77mg/dL vs. CG: -2.64mg/dL; p=0.053). There was also a significant reduction from baseline in incremental Area under the Curve (iAUC) (p=0.01) in the intervention group (Δ -22 mg) compared to the control group (Δ -7.9 mg) with a corresponding reduction in the Mean Amplitude of Glycemic Excursion (MAGE) (P=0.04). There was no difference between groups in body weight, waist circumference, blood pressure, and lipid profile. None of the subjects in the study reported serious adverse events. CONCLUSION: This pilot study showed that a diabetes specific nutritional supplement was useful in improving glycemic control and reducing glycemic response in overweight and obese Asian Indian adults with T2DM.