Department of Pediatric Endocrinology and Diabetology, Charité Children's Hospital, Universitätsmedizin Berlin, Augustenburger Platz 1, Berlin, Germany.
Eur J Endocrinol. 2010 Oct;163(4):585-92. doi: 10.1530/EJE-10-0570. Epub 2010 Jul 16.
To study whether metformin reduces obesity, homeostasis model assessment for insulin resistance index (HOMA-IR), and the metabolic syndrome (MtS) in obese European adolescents in addition to previous unsuccessful lifestyle intervention.
After 6 months of multiprofessional lifestyle intervention, 70 out of 86 adolescents without improvement in body mass index (BMI) and HOMA-IR were randomized into either the placebo (n=34) or the metformin group (2×500 mg/day, n=36) in addition to ongoing lifestyle intervention for another 6 months.
Age was 13.8 years, BMI was 33.1 kg/m(2), 65% were female, and 89% were Caucasians. During lifestyle intervention alone, BMI and HOMA-IR deteriorated significantly. In the subsequent medication period, HOMA-IR and fasting insulin improved similarly in the placebo and metformin groups (HOMA-IR decreased 73 vs 54% respectively in metformin versus placebo; P=0.048), but BMI remained unchanged. The insulin sensitivity index, however, only improved in the metformin group. High fasting insulin is correlated with a subsequent BMI increase irrespective of the medication. MtS remained unchanged.
Obese European adolescents' insulin sensitivity improved without weight change during placebo or metformin intervention in addition to lifestyle intervention. Most differences did not reach statistical significance, probably due to improved compliance with lifestyle intervention as a placebo effect. In addition, the metformin dose may be too low.
研究二甲双胍是否除了既往不成功的生活方式干预之外，还能减少肥胖、胰岛素抵抗指数（HOMA-IR）和代谢综合征（MtS）在肥胖欧洲青少年中的发生。
在经过 6 个月的多专业生活方式干预后，86 名青少年中有 70 名的体重指数（BMI）和 HOMA-IR 没有改善，他们被随机分为安慰剂组（n=34）或二甲双胍组（2×500mg/天，n=36），除了持续的生活方式干预外，还另外进行了 6 个月的干预。
年龄为 13.8 岁，BMI 为 33.1kg/m²，65%为女性，89%为白种人。在单独进行生活方式干预期间，BMI 和 HOMA-IR 显著恶化。在随后的药物治疗期间，安慰剂组和二甲双胍组的 HOMA-IR 和空腹胰岛素均得到相似改善（二甲双胍组 HOMA-IR 下降 73%，安慰剂组下降 54%；P=0.048），但 BMI 保持不变。然而，胰岛素敏感指数仅在二甲双胍组中得到改善。高空腹胰岛素与随后的 BMI 增加相关，而与药物无关。MtS 保持不变。
在生活方式干预的基础上，肥胖的欧洲青少年的胰岛素敏感性在接受安慰剂或二甲双胍干预时得到改善，而体重没有变化。大多数差异没有达到统计学意义，可能是由于生活方式干预的依从性改善作为安慰剂效应所致。此外，二甲双胍的剂量可能太低。
