Clarson Cheril L, Brown Hilary K, De Jesus Stefanie, Jackman Michelle, Mahmud Farid H, Prapavessis Harry, Robinson Tracy, Shoemaker J Kevin, Watson Margaret, Dowd A Justine, Hill David J
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.
Department of Epidemiology & Biostatistics, University of Western Ontario, London, ON, Canada N6A 5A5.
Int Sch Res Notices. 2014 Nov 10;2014:659410. doi: 10.1155/2014/659410. eCollection 2014.
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 .
目的。评估综合强化生活方式干预联合缓释二甲双胍（MXR）或安慰剂对肥胖青少年体重指数（BMI）以及2型糖尿病和心血管疾病风险因素的影响。研究设计。69名肥胖青少年（平均BMI为32.5）接受了为期24个月的综合生活方式干预，包括结构化饮食、体育活动和行为干预。受试者被随机分为4组中的1组：MXR组（33人），每日服用2000毫克或安慰剂，并在前3个月进行中等强度或高强度运动。随后，所有4组的运动干预相同。结果。人体测量指标在任何时候都不会因初始运动强度而有所不同。3个月时，所有4组的体脂百分比均下降（P < 0.006）。在6个月（-0.88，-3.16）和12个月（-0.56，-2.34）时，MXR组的BMI和体脂百分比下降，而安慰剂组则未下降（P < 0.05）。所有组在6个月和12个月时胰岛素抵抗、空腹血糖和瘦素水平均有所改善。到24个月时，受试者流失率较高（58%）。结论。综合强化生活方式干预联合MXR在1年时可使BMI和体脂百分比下降，且与初始运动强度无关。本试验已在ClinicalTrials.gov注册，注册号为NCT00934570。
