A single-centre, 6-month trial in severely overweight children with hyperinsulinemia and insulin resistance has demonstrated that metformin can improve symptoms of metabolic syndrome when administered twice a day in conjunction with a standardized weight-loss program. Jack Yanovski, MD, PhD, Growth and Obesity, Developmental Endocrinology Branch, National Institutes of Health Unit, presented the results of the randomized, double-blind, placebo-controlled trial at the Endocrine Society’s 90th Annual Meeting (ENDO 08).
Dr. Yanovski and colleagues recruited 100 overweight children 6 to 12 years old (mean 10.2 years). The cohort was 60% female, 11% Hispanic, 3% Asian, and 40% African American.
The researchers measured each patient’s body mass index (BMI), lipid levels, body composition, and homeostasis model assessment for insulin resistance (HOMA-IR) prior to and after 6 months of treatment. Fifty-three patients received metformin 1,000 mg twice daily and 47 received placebo.
Throughout the treatment period, all participants received a daily vitamin supplement and participated in a monthly weight-loss program administered by a dietician.
Approximately 85% of participants completed the trial (84% metformin, 86% placebo) with the remaining participants withdrawing due to lack of parental support or insufficient weight loss.
After 6 months of treatment, BMI was reduced among participants in the metformin group compared with placebo. Participants in the metformin group also achieved improved Z scores for BMI (-0.11 vs -0.04, P = .02) and reduced body fat mass (-1.4 kg vs +2.1 kg, P < .001).
Participants in the metformin group also achieved improved serum glucose levels (-2.4 mg/dL vs +1.6 mg/dL, P = .018) and exhibited improved HOMA-IR (-0.19 vs +0.95, P = .05). Total cholesterol levels were lower in the metformin group than in the placebo group after 6 months of treatment (-9.9 vs +1.1, P = .04).
Although all participants maintained normal serum vitamin B12 concentrations throughout the study, Dr. Yanovski noted that levels in the metformin group decreased by 7,226 pg/mL while levels in the placebo group increased by 7,730 pg/mL (P < .001). In addition, participants in the metformin group initially reported an increase in nausea, fatigue, and the number of liquid stools, with a decline in reports over time.
"Although metformin is only modestly effective for weight reduction for obese children with hyperinsulinemia, it does improve some of the aspects of metabolic syndrome," Dr. Yanovski concluded. "We believe that data from longer trials are needed before metformin can be recommended as a routine treatment for obese children."
[Presentation title: A Randomized, Placebo-Controlled Trial of the Effects of Metformin on Body Weight and Body Composition in Children With Insulin Resistance. Abstract OR25-5]
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