Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in the Treatment of Type 2 Diabetes Mellitus. Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Rate of resolution of type 2 diabetes
研究概览
简要总结
Obesity is a growing epidemic throughout the world and is followed by increasing incidence of type 2 diabetes that accounts for 90-95% of all cases of diabetes. Weight loss is a major objective, although difficult to achieve with medical treatments. Many recent studies demonstrated that bariatric surgery has the potency to achieve marked and sustained weight loss, and is also associated with a significant improvement in control of type 2 diabetes. The principal aim of this study is to compare two types of bariatric procedures, the Roux-en-Y gastric bypass (RYGBP) and sleeve gastrectomy (SG). The study hypothesis is that these procedures have equal efficacy with regard to resolution of type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
- •BMI between 35 and 50kg/m
- •Males and females
- •Age between 18 and 60 years.
排除标准
- •Severe ongoing psychiatric disorder, alcoholism and substance abuse.
- •Redo operations after previous bariatric procedures.
- •Type 1 diabetes or other non-type 2 forms of diabetes
- •End stage renal disease, retinopathy, neuropathy
结局指标
主要结局
Rate of resolution of type 2 diabetes
时间窗: 5 years
次要结局
- postoperative complications(5 years)