Metformin in the Management of Childhood Obesity: A Randomized Control Trial

Abstract

BACKGROUND: Childhood obesity-related metabolic derangements are increasing among South Asian populations. Dietary and physical activity plans have limited effect. This study aims to assess the effectiveness of metformin in the management of obesity among 8- to 16-year-old children in Gampaha District of Sri Lanka. MATERIALS AND METHODS: A triple-blinded controlled trial was conducted on 150 obese school children. After 12-hour overnight fast, blood was drawn for fasting blood glucose (FBG) and lipid profile. Anthropometry, fat mass (FM), and blood pressure were measured. BMI and insulin resistance were calculated. Children randomly received either metformin (8-10 years-500 mg 12 hourly; 11-16 years-1 g 12 hourly) or placebo. Anthropometry and blood investigations were repeated at 6 and 12 months. Mean difference in outcome measures, adjusted for baseline values, was compared using ANCOVA. RESULTS: There were 84/150 boys. Metabolic syndrome was present in 25 (16.7%). A statistically significant adjusted mean reduction was observed in the metformin group compared with placebo, in weight (-0.991 vs. 1.394, p = 0.000), BMI/Age-standard deviation score (SDS; -0.287 vs. -0.116, p = 0.000), %FM/Age-SDS (-0.092 vs. 0.016, p = 0.04), systolic blood pressure (SBP; -0.415 vs. 0.015, p = 0.015), total cholesterol (-0.95 vs. -0.7, p = 0.001), low-density lipoprotein (-0.67 vs. -0.45, p = 0.001), and highly sensitive C-reactive protein (-1.36 vs. 0.08, p = 0.013) at 6 months, and in BMI/Age-SDS (-370 vs. -0.222, p = 0.001), WC/Age-SDS (-0.473 vs. -0.337, p = 0.018), SBP (-0.834 vs. -0.477, p = 0.023), and triglycerides (-0.33 vs. -0.14, p = 0.019) at 12 months. CONCLUSIONS: Metformin compared with placebo has beneficial effects on anthropometric and metabolic indicators in the management of childhood obesity.