title: Effects of a Comprehensive, Intensive Lifestyle Intervention Combined with Metformin Extended Release in Obese Adolescents.
abstract: Objective. To assess a comprehensive, intensive lifestyle intervention in combination with metformin extended release (MXR) or placebo on body mass index (BMI) and risk factors for type 2 diabetes and cardiovascular disease in obese adolescents. Study Design. Sixty-nineobese adolescents (mean BMI 32.5) received a comprehensive lifestyle intervention with structured dietary, physical activity, and behavioral components for 24 months. Subjects were randomized to 1 of 4 groups: MXR (33) 2,000 mg daily or placebo, with either moderate or vigorous intensity exercise for the first 3 months. Subsequently the exercise intervention was the same for all 4 groups. Results. Anthropometry measurements did not differ with initial exercise intensity at any time. At 3 months % body fat decreased in all 4 groups (P < 0.006). BMI and % body fat decreased in the MXR groups, but not the placebo groups, at 6 (-0.88, -3.16) and 12 months (-0.56, -2.34) (P < 0.05). Insulin resistance, fasting blood glucose, and leptin improved in all groups at 6 and 12 months. A high subject attrition rate (58%) occurred by 24 months. Conclusion. A comprehensive, intensive lifestyle intervention combined with MXR led to a decline in BMI and % body fat at 1 year independent of initial exercise intensity. This trial is registered with ClinicalTrials.gov NCT00934570 .
authors.affiliation: Children's Hospital, London Health Sciences Centre, P.O. Box 5010, London, ON, Canada N6A 5W9; Lawson Health Research Institute, University of Western Ontario, London, ON, Canada N6A 5A5; Department of Paediatrics, University of Western Ontario, London, ON, Canada N6A 5A5.
authors.forename: Cheril L
authors.initials: CL
authors.lastname: Clarson
authors.affiliation: Department of Epidemiology & Biostatistics, University of Western Ontario, London, ON, Canada N6A 5A5.
authors.forename: Hilary K
authors.initials: HK
authors.lastname: Brown
authors.affiliation: School of Kinesiology, University of Western Ontario, London, ON, Canada N6A 5A5.
authors.forename: Stefanie
authors.initials: S
authors.lastname: De Jesus
authors.affiliation: Children's Hospital, London Health Sciences Centre, P.O. Box 5010, London, ON, Canada N6A 5W9.
authors.forename: Michelle
authors.initials: M
authors.lastname: Jackman
authors.affiliation: Children's Hospital, London Health Sciences Centre, P.O. Box 5010, London, ON, Canada N6A 5W9.
authors.forename: Farid H
authors.initials: FH
authors.lastname: Mahmud
authors.affiliation: School of Kinesiology, University of Western Ontario, London, ON, Canada N6A 5A5.
authors.forename: Harry
authors.identifier: 0000-0003-0636-7316
authors.initials: H
authors.lastname: Prapavessis
authors.affiliation: Children's Hospital, London Health Sciences Centre, P.O. Box 5010, London, ON, Canada N6A 5W9.
authors.forename: Tracy
authors.identifier: 0000-0001-5755-9452
authors.initials: T
authors.lastname: Robinson
authors.affiliation: School of Kinesiology, University of Western Ontario, London, ON, Canada N6A 5A5.
authors.forename: J Kevin
authors.initials: JK
authors.lastname: Shoemaker
authors.affiliation: Children's Hospital, London Health Sciences Centre, P.O. Box 5010, London, ON, Canada N6A 5W9.
authors.forename: Margaret
authors.identifier: 0000-0003-2948-5788
authors.initials: M
authors.lastname: Watson
authors.affiliation: School of Kinesiology, University of Western Ontario, London, ON, Canada N6A 5A5.
authors.forename: A Justine
authors.initials: AJ
authors.lastname: Dowd
authors.affiliation: Lawson Health Research Institute, University of Western Ontario, London, ON, Canada N6A 5A5; Department of Medicine, University of Western Ontario, London, ON, Canada N6A 5A5; Department of Physiology and Pharmacology, University of Western Ontario, London, ON, Canada N6A 5A5.
authors.forename: David J
authors.initials: DJ
authors.lastname: Hill