Prospective Randomized Trials of Gastric Bypass Surgery in Patients With Type II Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Measure sugar levels, HbA1c levels, and medication needed. OGTT, MGTT.
研究概览
简要总结
Although intensive medical treatment of diabetes has clearly been demonstrated to be worthwhile, it has not been a total success in diabetes treatment for a variety of reasons including lack of response to medication. Diabetes has been well demonstrated as a co-morbidity illness of obesity patients. In observation, with exclusion stomach and duodenum of bariatric surgery (gastric bypass), most morbidly obese patients (about 80%) with diabetes had a significant improved of sugar control. Base of this observation, we will try to find out the role surgical intervention (gastric bypass & sleeve gastrectomy) in obese-related diabetes.
详细描述
In observation, with exclusion stomach and duodenum of bariatric surgery (gastric bypass), most morbidly obese patients (about 80%) with diabetes had a significant improved of sugar control. Base on this observation, we will try to find out the role surgical intervention (gastric bypass and sleeve gastrectomy) in obese-related diabetes. With restriction of stomach volume and with or without duodenal exclusion, this randomized trials will find out the role of duodenal exclusion and the role of Ghrenin in obese-related type II DM patients. The initial observation of previous morbidly obese patients with type II DM, the DM seems a chronic disease which could be treated or controlled by surgical intervention, that's what we try to know more.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with diagnosis of T2DM for at least 6 months
- •Mild to moderate obesity status(BMI 27 - 35 )
- •Age : 30 - 60 year-old
- •HbA1C > 8 %
排除标准
- •With co-morbidity illness of cardiovascular system
- •DM related nephropathy (Cre >2.0 mg/dl)
- •Pulmonary embolism or uncontrolled coagulopathy in 6 months
- •HBV or HCV hepatitis or liver cirrhosis, inflammatory colon disease, Cushing syndrome
- •s/p organ transplantation
- •Previously Bariatric surgery, gastrointestinal surgery, or abdominal sepsis
- •Alcoholic or drug abuser
- •Psychological disease.
- •HIV or TB patient
结局指标
主要结局
Measure sugar levels, HbA1c levels, and medication needed. OGTT, MGTT.
时间窗: 1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th months
次要结局
- Comparing the DM controls between Medical and Surgical treatment In surgery groups, compare the bypass surgery and sleeve gastrectomy(1 yr)