NCT00487526Unknown1 期
Clinical Evaluation of the Effect of Duodenal Jejunal Bypass on Type Two Diabetes in Non Obese Adults
Ferzli, George S., M.D. F.A.C.S.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2007年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- control of type 2 diabetes in non obese adults
研究概览
简要总结
Study the effect of Duodenal jejunal bypass on human adults with type 2 diabetes.
详细描述
Adults non obese ( BMI less than 34 ) will undergo duodenal jejunal bypass. The Outcome measures: Blood Sugar, Insulin,HbA1c, CCK,Gastrin, GIP1and 2, Ghrelin, Cholesterol, Triglycerides,FFA, C-Peptide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults age 20-65
- •Clinical diagnosis of type 2 diabetes
- •Non obese with BMI less than
- •Oral agents or insulin to control T2DM.
- •Inadequate control of diabetes as defined as HbA1c>/7.5
- •Understanding of the mechanisms of action of the treatment
排除标准
- •Children with type 1 diabetes
- •Obese with BMI over 34
- •Coagulopathy
- •Liver cirrhosis
- •Unable to comply with study requirements, follow-up or give valid consent
- •Currently pregnant
- •Previous upper abdominal surgery
- •Inabilty to tolerate general anesthesia
结局指标
主要结局
control of type 2 diabetes in non obese adults
时间窗: two years
次要结局
- CCK FFA,Cholesterol,Ghrelin,C-peptide,HbA1c,Gastrin,GIP,Triglycerides,Insulin(2 years)
研究者
研究点 (1)
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