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| Effects of a comprehensive, intensive lifestyle intervention combined with metformin extended release in obese adolescents |
| Clarson CL, Brown HK, de Jesus S, Jackman M, Mahmud FH, Prapavessis H, Robinson T, Shoemaker JK, Watson M, Dowd AJ, Hill DJ |
| International Scholarly Research Notices 2014 Nov 10;(659410):Epub |
| clinical trial |
| 7/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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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-nine obese 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) 2,000mg 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 to -3.16) and 12 months (-0.56 to -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.
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