Metformin Extended Release Treatment of Adolescent Obesity: A 48-Week Randomized, Double-Blind, Placebo-Controlled Trial With 48-Week Follow-up | Adolescent Medicine | JAMA Pediatrics | JAMA Network
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Article
Journal Club
February 2010

Metformin Extended Release Treatment of Adolescent Obesity: A 48-Week Randomized, Double-Blind, Placebo-Controlled Trial With 48-Week Follow-up

Author Affiliations

Author Affiliations: Authors: Darrell M. Wilson MD (chair); Stephanie H.AbramsMD; TandyAyeMD; Phillip D. K.LeeMD; CarineLendersMD, MS, ScD; Robert H.LustigMD; Stavroula V.OsganianMD, ScD; Henry A.FeldmanPhD.

Arch Pediatr Adolesc Med. 2010;164(2):116-123. doi:10.1001/archpediatrics.2009.264
Abstract

Background  Metformin has been proffered as a therapy for adolescent obesity, although long-term controlled studies have not been reported.

Objective  To test the hypothesis that 48 weeks of daily metformin hydrochloride extended release (XR) therapy will reduce body mass index (BMI) in obese adolescents, as compared with placebo.

Design  Multicenter, randomized, double-blind, placebo-controlled clinical trial.

Setting  The 6 centers of the Glaser Pediatric Research Network from October 2003 to August 2007.

Participants  Obese (BMI≥95th percentile) adolescents (aged 13-18 years) were randomly assigned to the intervention (n = 39) or placebo groups.

Intervention  Following a 1-month run-in period, subjects following a lifestyle intervention program were randomized 1:1 to 48 weeks' treatment with metformin hydrochloride XR, 2000 mg once daily, or an identical placebo. Subjects were monitored for an additional 48 weeks.

Main Outcome Measure  Change in BMI, adjusted for site, sex, race, ethnicity, and age and metformin vs placebo.

Results  After 48 weeks, mean (SE) adjusted BMI increased 0.2 (0.5) in the placebo group and decreased 0.9 (0.5) in the metformin XR group (P = .03). This difference persisted for 12 to 24 weeks after cessation of treatment. No significant effects of metformin on body composition, abdominal fat, or insulin indices were observed.

Conclusion  Metformin XR caused a small but statistically significant decrease in BMI when added to a lifestyle intervention program.

Trial Registration  clinicaltrials.gov Identifiers: NCT00209482 and NCT00120146

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