Weight loss and metabolic effects of topiramate in overweight and obese type 2 diabetic patients:: randomized double-blind placebo-controlled trial
Weight loss and metabolic effects of topiramate in overweight and obese type 2 diabetic patients:: randomized double-blind placebo-controlled trial
复制标题
DOI：
10.1038/sj.ijo.0803548
复制
发表时间：
2007-07-01
影响因子：
4.9
通讯作者：
Smith, U.
中科院分区：
文献类型：
--
作者：
Eliasson, B.;Gudbjornsdottir, S.;Smith, U.
目的：检查托吡酯治疗肥胖 2 型糖尿病患者 (DM2) 11 个月后的代谢影响和身体成分变化。 设计和受试者：38 名接受饮食或磺脲类药物治疗的 DM2 参加了这项随机双盲安慰剂对照试验。十三名接受安慰剂治疗的患者和九名接受托吡酯治疗的患者完成了试验。患者被随机接受托吡酯 96 mg b.i.d 治疗。或安慰剂（6 周磨合期、2 个月滴定期、9 个月维持期）。 测量：用正常血糖高胰岛素钳测量胰岛素敏感性。定期测量体重、糖化血红蛋白、空腹血糖、血脂和安全变量。通过计算机断层扫描确定身体成分。进行膳食测试以评估餐后血糖和胰岛素水平。进行三天饮食回顾以评估能量摄入情况。结果：平均年龄为 58.6 +/- 7.1 岁，体重 98.1 +/- 16.1 kg，BMI 33.0 +/- 4.5 kg/m(2)，糖化血红蛋白 (HbA1c) 7.3 +/- 0.9%。在托吡酯治疗的患者中，HbA1c（1.170.9%）、空腹血糖、体重（-6.673.3%）以及体脂、去脂体重、餐后血糖和游离脂肪酸水平显着降低，但胰岛素敏感性没有显着变化。托吡酯组的每日平均能量摄入量比安慰剂组下降更多。感觉异常和中枢神经系统相关副作用是退出率的主要原因。 结论：托吡酯治疗超重 DM2 可以降低体重和体脂，并与血糖控制显着改善相关，但胰岛素刺激的葡萄糖摄取没有显着改善。需要进一步的研究来阐明这种效应是否可能通过肝脏和/或胰腺胰岛素分泌的胰岛素敏感性变化而发生。
Objective: To examine the metabolic effects and body composition changes after topiramate treatment of obese type 2 diabetic patients (DM2)for 11 months.Design and subjects: Thirty-eight DM2 on diet or sulfonylurea treatment participated in this randomized double-blind placebo-controlled trial. Thirteen placebo-treated and nine topiramate-treated patients completed the trial. Patients were randomized to treatment with topiramate 96 mg b.i.d. or placebo (6-week run-in phase, 2-months titration phase, 9-months maintenance phase).Measurements: Insulin sensitivity was measured with euglycaemic hyperinsulinemic clamps. Weight, HbA1c, fasting glucose, blood lipids and safety variables were measured at regular intervals. Body composition was determined with computerized tomography. Meal tests were performed to evaluate postprandial glucose and insulin levels. Three-day diet recalls were carried out to evaluate energy ingestion.Results: The mean age was 58.6 +/- 7.1 years, body weight 98.1 +/- 16.1 kg, BMI 33.0 +/- 4.5 kg/m(2), and glycosylated hemoglobin (HbA1c) 7.3 +/- 0.9%. In topiramate-treated patients, there were significant reductions in HbA1c (1.170.9%), fasting plasma glucose, body weight (-6.673.3%), as well as body fat, lean body mass, postprandial glucose and free fatty acid levels but there were no significant changes in insulin sensitivity. The daily average energy intake decreased more in the topiramate group than in the placebo group. Paresthesia and central nervous system-related side effects were the main causes for the dropout rate.Conclusions: Topiramate treatment of overweight DM2 reduced body weight and body fat, and was associated with a marked improvement in glycaemic control whereas no significant improvement in insulin-stimulated glucose uptake was demonstrated. Further studies are required to clarify whether this effect might occur through changes in insulin sensitivity in the liver and/or pancreatic insulin secretion.