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• W1522254549 abstract "<h3>Background</h3> Metformin has been proffered as a therapy for adolescent obesity, although long-term controlled studies have not been reported. <h3>Objective</h3> 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. <h3>Design</h3> Multicenter, randomized, double-blind, placebo-controlled clinical trial. <h3>Setting</h3> The 6 centers of the Glaser Pediatric Research Network from October 2003 to August 2007. <h3>Participants</h3> Obese (BMI≥95th percentile) adolescents (aged 13-18 years) were randomly assigned to the intervention (n = 39) or placebo groups. <h3>Intervention</h3> 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. <h3>Main Outcome Measure</h3> Change in BMI, adjusted for site, sex, race, ethnicity, and age and metformin vs placebo. <h3>Results</h3> 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 (<i>P</i> = .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. <h3>Conclusion</h3> Metformin XR caused a small but statistically significant decrease in BMI when added to a lifestyle intervention program. <h3>Trial Registration</h3> clinicaltrials.gov Identifiers:NCT00209482andNCT00120146" @default.
• W1522254549 created "2016-06-24" @default.
• W1522254549 date "2010-02-01" @default.
• W1522254549 modified "2023-09-26" @default.
• W1522254549 title "Metformin Extended Release Treatment of Adolescent Obesity" @default.
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• W1522254549 doi "https://doi.org/10.1001/archpediatrics.2009.264" @default.
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