The Curative Effect of the Length of the Jejunum Exclusion in Grstric Bypass Surgery for Type 2 Diabetes:a Randomized Controlled Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- body mass idex
研究概览
简要总结
The purpose of this study is to investigate the curative effect of the length of the jejunum exclusion in gastric surgry for T2DM and metabolic syndrome,and to draft Scientific and reasonable operation parameters.
详细描述
Currently, there is a growing evidence supports the efficacy of Roux-en-Y gastric bypass for the treatment of Type 2 diabetes mellitus. However,there still have a great controversy about the operation parameters. With randomized controlled trial, Patients of BMI>21kg/m2 with type 2 diabetes were randomly divided into two groups: short biliarypancreatic limb:50cm;long biliarypancreatic limb :100cm. The investigators followed-up 3,6,12,24 months of the change of BMI,FBG,HbA1c,Blood pressure,Blood fat after surgery.
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 (Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 20-65 years old
- •History of diabetes is less than 15 years
- •Fasting c-peptide≥1.6
- •BMI≥21kg/m2；
- •Ability to understand the nature of the procedure and willing to follow postoperative routine lifestyle and checkups
排除标准
- •Psychological and mental disorders
- •Serious important organs such as heart and lung disease cannot be tolerated surgery
- •Complex history of abdominal surgery in the abdominal cavity adhesion
- •Pregnancy or lactation
研究组 & 干预措施
short biliarypancreatic limb
short biliarypancreatic limb
干预措施: short biliarypancreatic limb (Procedure)
long biliarypancreatic limb
long biliarypancreatic limb
干预措施: long biliarypancreatic limb (Procedure)
结局指标
主要结局
body mass idex
时间窗: 24 months
Changesd of BMI
次要结局
- IFG(24 months)
- HbA1c(24 months)
- blood pressure(24 months)
- blood fat(24 months)
研究者
Weidong Tong
Gastric & Colorectal Division, General Surgery Dept. Daping Hospital
Third Military Medical University