Metformin extended release treatment of adolescent obesity: A 48-week randomized, double-blind, placebo-controlled trial with 48-week follow-up

Darrell M. Wilson, Stephanie H. Abrams, Tandy Aye, Phillip D.K. Lee, Carine Lenders, Robert H. Lustig, Stavroula V. Osganian, Henry A. Feldman, Patricia Fechner, Thomas Robinson, Bruce Buckingham, Trudy Esrey, Keniki McNeil, Beatrice Sorensen, Kirsten Wilson, Jeanne Davis, William Klish, Stephanie Abrams, Pam Holt, Cynthia EdwardsLinda Howard, Stephen Gitelman, Marcia Wertz, Jessica Breland, Tania Lihatsh, Anna Haddal, Pinchas Cohen, Sally Shupien, Janet Mooney, Elena Khanukhova, Helene Cohen, George Taylor, Christopher Duggan, Sam Nurko, Carol Sweeney, Katie Zhang, Maggie McCarthy, Michael Wake, Rajna Filip-Dhima, Charles Prober, Karen Urbanek, Alisa Kim, Anita Kelley, Christine Crabtree, Dennis Styne, Michael Gottschalk, Daniel Hale, Heidi Krause-Steinrauf

Research output: Contribution to journalArticlepeer-review

116 Scopus citations


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, placebocontrolled 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, 2000mgonce 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: Identifiers: NCT00209482 and NCT00120146.

Original languageEnglish (US)
Pages (from-to)116-123
Number of pages8
JournalArchives of Pediatrics and Adolescent Medicine
Issue number2
StatePublished - Feb 2010
Externally publishedYes

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health


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