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, Glaser Pediatric Research Network Obesity Study Group, Darrell M Wilson, Patricia Fechner, Tandy Aye, Thomas Robinson, Bruce Buckingham, Trudy Esrey, Keniki McNeil, Beatrice Sorensen, Kirsten Wilson, Jeanne Davis, William Klish, Stephanie Abrams, Pam Holt, Cynthia Edwards, Linda Howard, Stephen Gitelman, Robert Lustig, Marcia Wertz, Jessica Breland, Tania Lihatsh, Phillip D K Lee, Anna Haddal, Pinchas Cohen, Sally Shupien, Janet Mooney, Elena Khanukhova, Helene Cohen, Carine Lenders, George Taylor, Christopher Duggan, Sam Nurko, Carol Sweeney, Katie Zhang, Darrell M Wilson, Stephanie H Abrams, Tandy Aye, Phillip D K Lee, Carine Lenders, Robert H Lustig, Stavroula V Osganian, Henry A Feldman, Glaser Pediatric Research Network Obesity Study Group, Darrell M Wilson, Patricia Fechner, Tandy Aye, Thomas Robinson, Bruce Buckingham, Trudy Esrey, Keniki McNeil, Beatrice Sorensen, Kirsten Wilson, Jeanne Davis, William Klish, Stephanie Abrams, Pam Holt, Cynthia Edwards, Linda Howard, Stephen Gitelman, Robert Lustig, Marcia Wertz, Jessica Breland, Tania Lihatsh, Phillip D K Lee, Anna Haddal, Pinchas Cohen, Sally Shupien, Janet Mooney, Elena Khanukhova, Helene Cohen, Carine Lenders, George Taylor, Christopher Duggan, Sam Nurko, Carol Sweeney, Katie Zhang

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 > or = 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.

Figures

Figure 1
Figure 1
Disposition of subjects. “Withdrew” refers to withdrawal of consent. One subject in the metformin hydrochloride extended release group withdrew consent at week 16 but returned for a measurement at week 100 (end of study). See text for further details.
Figure 2
Figure 2
Body mass index (BMI) (calculated as mean weight in kilograms divided by mean height in meters squared) (A) and adjusted change in BMI from baseline (B) (see text for further details). Data are plotted as the mean and 1 SE. Vertical dotted lines separate the study drug treatment (4–52 weeks) and post–study drug treatment (52–100 weeks) monitoring periods. Part A includes data for the run-in period (0–4 weeks). Metformin was given as metformin hydrochloride extended release.

Source: PubMed

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