NCT00694278Unknown不适用
Clinical Evaluation of the Effect of Duodenal-Jejunal Bypass on Type 2 Diabetes in 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 15 人开始时间: 2008年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 1
研究概览
简要总结
The aim of this study and the primary outcome is to clinically evaluate effect of laparoscopic duodenal-jejunal bypass on non-obese type 2 diabetes. Secondary outcomes will evaluate CCK, FFA, Cholesterol Ghrelin, C-peptide, and HbA1c levels. Patients will be followed closely to ensure the desired results are sustained in long term
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- 是
入选标准
- •Adults age 20-65 years
- •Clinical diagnosis of type II diabetes buy on of the following three criteria (American Diabetes Association)
- •A normal or high C-peptide level (to exclude type 1 diabetes) (>.9ng/ml)
- •A random plasma glucose of 200mg/dl or more with typical symptom of diabetes
- •A fasting plasma glucose of 126mg/dl or more on more than one occasion
- •BMI 22-34 KG/m2
- •Patients on oral hypoglycemic medications or insulin to control T2DM
- •Inadequate control of diabetes as defined as HbA1c>7.5
- •No contraindication for surgery or General Anesthesia as determined by multidisciplinary surgical team
- •Ability to understand and describe the mechanism of action of ricks and benefits of the operation
排除标准
- •Patients who meet any of the following exclusion criteria will be exclusion criteria will be excluded from enrollment into the study
- •Enrolled in another clinical study which involves and investigational drug
- •Diagnosis type 1 diabetes
- •Pregnancy (all female patients will have beta HCG) or planned pregnancy within 2 years of entry into the study or unwilling to use reliable contraceptive method
- •Previous gastric or esophageal surgery
- •Immunosuppressive drugs including corticosteroids
- •Coagulopathy (INR>1.5 or platelets<50,000/ul)
- •Anemia (Hgb<10.0g/dl)
研究者
研究点 (1)
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