A Randomized Trial Study of Different Laparoscopic Gastric Bypass Surgery in Patients With Obesity-related T2DM
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Remission of diabetes
研究概览
简要总结
The investigators would like to conduct a randomized clinical trial to compare the efficacy of diabetes treatment between different gastric bypass procedures involving type 2 diabetics patients with BMI from 27.5 to 35 kg/m2
详细描述
The investigators would like to conduct a randomized clinical trial to compare the efficacy of diabetes treatment between different gastric bypass procedures involving type 2 diabetics patients with BMI from 27.5 to 35 kg/m2. This program will determine the relative effectiveness among LMGB 、RYGB and SADJB .The primary end point including HbA1C<6.0%, LDL-C<100mg/dl and SBP<130mmHg at one year after surgery. Through this study, the investigators may understand which gastric bypass is the best for type 2 diabetic's treatment. The investigators also hope some new treatment modulation may be developed.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 to 67 years
- •Diagnosed with T2DM at least 6 months prior to enrollment, under the active care of a doctor for at least the six months prior to enrollment, HbA1c ≥ 7.5 %
- •Body Mass Index (BMI) ≥ 27.5 kg/m 2 and ≤ 34.9 kg/m 2
- •Willingness to accept random assignment to either treatment group.
- •Willingness to comply with the follow-up protocol
- •Written informed consent.
排除标准
- •Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
- •Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
- •Cardiac stress test indicating that surgery would not be safe.
- •Pulmonary embolus or thrombophlebitis in the past six months
- •Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years
- •Serum creatinine ≥ 1.5 mg/dl
- •History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection
- •Previous organ transplantation.
- •History of alcohol or drug dependency
- •Current participation in a conflicting research protocol.
结局指标
主要结局
Remission of diabetes
时间窗: two years
remission of Diabetes Mellitus Type 2 after different types of Gastric bypass surgery
次要结局
- weight loss and improvement in quality of life(2 years)
研究者
WEI-CHENG YAO
Department of Surgery
Min-Sheng General Hospital