Serum Proteomics Research in Bypassing Surgery to Treat Type 2 Diabetes in China
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- different proteins detected between obese persons, type 2 diabetes patients prior to surgery, 10 days after surgery and 3 months after surgery.
研究概览
简要总结
The purpose of this study is to reveal the key proteins involved in gastric bypassing surgery which may effect the decreased glucose in type 2 diabetes patietns, and evaluate standard remission rate as well as cost-benefit of gastric bypassing surgery for type 2 diabetes mellitus patients in China.
详细描述
Diabetes Mellitus is a major global problem which responsibles for 4.6 million deaths each year without effective therapy methods. Recently，researchers showed that type 2 diabetes mellitus can be partly reversed by gastric bypassing surgery. However, surgeons are still not clear how to chose the proper diabetes patients for surgery as the mechanism is still not clear, and the remission rate of diabetes mellitus is not the same among different surgical procedures.
This study will enroll type 2 diabetes mellitus patients follwing Roux-en-Y gastric bypassing surgery and obese persons without type 2 diabetes surgery. The defferent expressions of serum proteins of obese persons without type 2 diabetes and type 2 diabetes patients following gastric bypassing surgery after 10 days or 3 months were detected by serum proteomics. Blood samples and urine will be taken prior to surgery, 10 days after surgery and 3 months after surgery. The long term prognosis of diabetes mellitus for 1 years and the remission rate of diabetes of patients will be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients diagnosed as type 2 diabetes are planning to have Roux-en-Y gastric bypass
- •age:18-65yr
- •HbAlc>8%
排除标准
- •diabetes (applies for control patients)
- •chronic inflammatory disease
- •malignant disease
- •pregnancy
- •prior gastric, duodenal, proximal jejunal surgery or pancreas resection
- •current use of thiazolidinediones
- •treatment with incretin mimetics or DPP IV inhibitors in the prior 3 months
- •HbAlc<8%
- •any condition felt by the investigator to interfere with ability to complete the study
结局指标
主要结局
different proteins detected between obese persons, type 2 diabetes patients prior to surgery, 10 days after surgery and 3 months after surgery.
时间窗: base line to 3 months
次要结局
- evaluating the change in glucose between the baseline evaluation and the follow-up evaluation.(1 year)