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目的二甲双胍可降低肥胖风险,改善肥胖相关的并发症,当然包括青少年的糖代谢紊乱,但是,旨在评估儿童群体使用二甲双胍的疗效很少。因此,我们的目标是,针对存在胰岛素抵抗的肥胖儿童群体,确定二甲双胍减轻体重和改善肥胖相关并发症的疗效。研究设计与方法这项研究是一项随机双盲安慰剂对照试验,纳入了100名存在胰岛素抵抗、年龄6～12岁、严重肥胖(BMI平均值为34.6±6.6kg/m2)的儿童,并被随机分配到二甲双胍组(N=53,1000mg/每日两次)或安慰剂组(N=47),6个月后,公开二甲双胍标签并继续治疗6个月。所有的儿童以及他们的双亲,参加每月一次的“营养师管理减重计划”。结果 85%完成了为期6个月的随机分配研究阶段。二甲双胍组的结果显著降低,包括BMI(降低1.09kg/m2,CI-1.87～-0.31,P=0.006),体重(降低3.38kg,CI-5.2～-1.57,P<0.001),BMI的Z分数(下降0.07,CI-0.12～-0.01,P=0.02),以及脂肪含量(减少1.40kg,CI-2.74～-0.06,P=0.04)。空腹血糖水平(P=0.007)、稳态模型评估(HOMA)法测定的胰岛素抵抗指数(P=0.006),获得的改善更多(和安慰剂组比较)。胃肠道症状在二甲双胍组更普遍,其中17%不能耐受最大剂量。在6个月的开放标签阶段,前安慰剂组儿童BMI的Z分数降低;而前二甲双胍组儿童BMI的Z分数并没有获得进一步的显著降低。结论对于存在胰岛素抵抗的肥胖儿童,二甲双胍可以适度降低体重、改善身体组成和糖代谢紊乱。
Aim Metformin may reduce the risk of obesity and improve obesity-related complications, including of course adolescent glucose metabolism disorders, but little is known about assessing the use of metformin in children. Therefore, our goal is to identify the efficacy of metformin in reducing weight and improving obesity-related complications in obese, obese child populations with insulin resistance. Study Design and Methods This study, a randomized, double-blind placebo-controlled trial, included 100 children with insulin resistance, ages 6 to 12, and severe obesity (mean BMI 34.6 ± 6.6 kg / m2) Patients were randomized to metformin (n = 53, 1000 mg twice daily) or placebo (n = 47). Metformin was released 6 months later and continued for 6 months. All children and their parents participate in the monthly Dietitian Management Weight Loss Program. Results 85% completed the 6-month randomized study phase. The results of metformin group were significantly lower, including BMI (1.09kg / m2, CI-1.87-0.31, P = 0.006), body weight (3.38kg, CI-5.2-1.57, P <0.001) (Decline 0.07, CI-0.12 -0.01, P = 0.02), and fat content (1.40 kg reduction, CI 2.74 -0.06, P 0.04). Fasting blood glucose levels (P = 0.007), and insulin resistance index (P = 0.006) as determined by the homeostasis model assessment (HOMA) improved more (compared with placebo). Gastrointestinal symptoms are more common in the metformin group, of which 17% can not tolerate the maximum dose. In the 6-month open-label phase, the Z-score for BMI in pre-placebo children decreased, whereas the Z-scores for BMI in pre-metformin groups did not decrease further significantly. Conclusion For obese children with insulin resistance, metformin may moderately reduce body weight and improve body composition and glucose metabolism disorder.