Metformin extended release treatment of adolescent obesity: a 48-week randomized, double-blind, placebo-controlled trial with 48-week follow-up.
Metformin extended release treatment of adolescent obesity: a 48-week randomized, double-blind, placebo-controlled trial with 48-week follow-up.
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二甲双胍的延长释放治疗青少年肥胖症：一项为期48周的随机，双盲，安慰剂对照试验，随访48周。
DOI：
10.1001/archpediatrics.2009.264
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发表时间：
2010-02
影响因子：
--
通讯作者：
Feldman, Henry A.
中科院分区：
文献类型：
--
作者：
Wilson, Darrell M.;Abrams, Stephanie H.;Aye, Tandy;Lee, Phillip D. K.;Lenders, Carine;Lustig, Robert H.;Osganian, Stavroula V.;Feldman, Henry A.
二甲双胍已被用作青少年肥胖症的治疗方法，尽管长期对照研究尚未见报道。为了验证与安慰剂相比，每日48周的盐酸二甲双胍缓释(XR)疗法将降低肥胖青少年的身体质量指数(BMI)的假设。多中心、随机、双盲、安慰剂对照临床试验。2003年10月至2007年8月，格拉泽儿科研究网络的6个中心。肥胖(体重指数≥第95百分位数)青少年(13-18岁)被随机分配到干预组(n=39)或安慰剂组。在1个月的磨合期后，遵循生活方式干预计划的受试者被随机分为1：1至48周的盐酸二甲双胍XR治疗，每天一次，2000毫克，或相同的安慰剂。受试者又被监测了48周。体重指数的变化，根据地点、性别、种族、民族和年龄以及二甲双胍与安慰剂进行调整。48周后，平均(SE)调整后的BMI在安慰剂组增加了0.2(0.5)，在二甲双胍XR组减少了0.9(0.5)(P=0.03)。这种差异在停止治疗后持续了12到24周。未观察到二甲双胍对身体成分、腹部脂肪或胰岛素指数的显著影响。当添加到生活方式干预计划中时，二甲双胍XR导致BMI略有下降，但在统计上有显著意义。
Metformin has been proffered as a therapy for adolescent obesity, although long-term controlled studies have not been reported. 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. Multicenter, randomized, double-blind, placebo-controlled clinical trial. The 6 centers of the Glaser Pediatric Research Network from October 2003 to August 2007. Obese (BMI≥95th percentile) adolescents (aged 13–18 years) were randomly assigned to the intervention (n = 39) or placebo groups. 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. Change in BMI, adjusted for site, sex, race, ethnicity, and age and metformin vs placebo. 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. Metformin XR caused a small but statistically significant decrease in BMI when added to a lifestyle intervention program.
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影响因子：
158.5
作者：
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