Randomized, controlled trial of metformin for obesity and insulin resistance in children and adolescents: Improvement in body composition and fasting insulin
Randomized, controlled trial of metformin for obesity and insulin resistance in children and adolescents: Improvement in body composition and fasting insulin
复制标题
DOI：
10.1210/jc.2006-0241
复制
发表时间：
2006-06-01
影响因子：
5.8
通讯作者：
Cowell, Christopher T.
中科院分区：
文献类型：
--
作者：
Srinivasan, Shubha;Ambler, Geoffrey R.;Cowell, Christopher T.
背景：二甲双胍治疗成人和儿童 2 型糖尿病的疗法已十分成熟。然而，其在治疗儿童和青少年胰岛素抵抗和肥胖方面的作用尚不明确。 目的：我们评估二甲双胍对外源性肥胖儿科受试者的身体成分和胰岛素敏感性的影响。 设计和设置：转诊至儿科内分泌诊所的患者参加了一项随机、双盲、交叉试验。 患者： 28 名 9-18 岁的患者（13 名男性）参与了这项研究。 干预： 患者接受二甲双胍（1每天两次）和安慰剂，为期 6 个月，每次有 2 周的清除期。主要结果指标：在基线、第 6 个月和第 12 个月测量身体成分（人体测量、双能 X 射线吸收测定法和腹部磁共振成像）和胰岛素敏感性（Si；最小模型、空腹胰岛素和血糖）。结果：受试者基线时的平均年龄为 12.5 +/- 2.2 岁，中位体重指数z 分数 2.54（范围：1.93-2.85）。与安慰剂相比，二甲双胍在体重（-4.35kg，P = 0.02）、体重指数（-1.26 kg/m(2)，P = 0.002）、腰围（-2.8cm，P = 0.003）、皮下腹部脂肪组织（-52.5 cm(2)，P = 0.002）和空腹胰岛素（-2.2 mU/L， P = 0.011）。服用二甲双胍的受试者中有 45% 的 Si 得到改善，服用安慰剂的受试者有 27% 的 Si 得到改善（P = 0.21）。结论：二甲双胍治疗肥胖胰岛素抵抗儿科患者可显着改善身体成分和空腹胰岛素。尽管许多人注意到 Si 有所改善，但 Si 对于分析群体数据来说并不是一个有用的参数，这可能是由于青春期顺应性变化和 Si 变化的影响。
Context: Metformin therapy for adults and children with type 2 diabetes is well established. However, its role in the treatment of insulin resistance and obesity in children and adolescents is less clearly defined.Objective: We assessed the effect of metformin on body composition and insulin sensitivity in pediatric subjects with exogenous obesity.Design and Setting: Patients referred to a pediatric endocrine clinic were enrolled in a randomized, double-blind, crossover trial.Patients: Twenty-eight patients (13 males) aged 9-18 yr participated in the study.Intervention: Patients received metformin (1 g twice daily) and placebo for 6 months, each with a 2-wk washout period.Main Outcome Measures: Body composition (anthropometry, dual-energy x-ray absorptiometry, and abdominal magnetic resonance imaging), and insulin sensitivity (Si; minimal model, fasting insulin and glucose) were measured at baseline and 6 and 12 months.Results: Mean age of subjects at baseline was 12.5 +/- 2.2 yr, median body mass index z-score 2.54 ( range, 1.93-2.85). Metformin had a greater treatment effect over placebo for weight (-4.35kg, P = 0.02), body mass index (-1.26 kg/m(2), P = 0.002), waist circumference (-2.8cm, P = 0.003), sc abdominal adipose tissue (-52.5 cm(2), P = 0.002), and fasting insulin (-2.2 mU/liter, P = 0.011). Si improved in 45% of subjects while on metformin and 27% of subjects while on placebo (P = 0.21).Conclusions: Metformin therapy for obese insulin-resistant pediatric patients results in significant improvement in body composition and fasting insulin. Although improvement in Si was noted in many individuals, Si was a less useful parameter for analysis of group data, possibly because of effects of variable compliance and changing Si during puberty.