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


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


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


METHODS
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.


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


BACKGROUND
clinicaltrials.gov Identifiers: NCT00209482 and NCT00120146.
Wilson
Darrell M
DM
Division of Pediatric Endocrinology and Diabetes, Stanford University and the Lucile Packard Children's Hospital at Stanford, G-313 Medical Center, Stanford, CA 94305-5208, USA. dwilson@stanford.edu
Abrams
Stephanie H
SH
Aye
Tandy
T
Lee
Phillip D K
PD
Lenders
Carine
C
Lustig
Robert H
RH
Osganian
Stavroula V
SV
Feldman
Henry A
HA
D000293:Adolescent; D000886:Anthropometry; D001823:Body Composition; D015992:Body Mass Index; D002118:Calcium / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D004032:Diet; D004311:Double-Blind Method; D005247:Feeding Behavior; D005260:Female; D005500:Follow-Up Studies; D015438:Health Behavior; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007333:Insulin Resistance / Q000502:physiology; D008019:Life Style; D008297:Male; D008687:Metformin / Q000627:therapeutic use*; D009765:Obesity / Q000188:drug therapy*; D013997:Time Factors; D014815:Vitamins / Q000627:therapeutic use
D003692:Delayed-Action Preparations; D007004:Hypoglycemic Agents; D014815:Vitamins; D008687:Metformin; D002118:Calcium