Metabolic Surgery for Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Hemoglobin A1C
研究概览
简要总结
Surgical treatment for type 2 diabetes has been taken note especially in less obese or non obese patients. In Asian, the nuber of less obses or non obese patients with T2DM is greater than that of the obese.
We are trying to do a prospective observational study for the evaluation of the effect of duidenojejunal bypass and gastric bypass on the glycemoc control in those patients.
The selection criteria are type 2 diabetess, 20-60 years old, BMI 23-34 or 21-22 with viceral obesity, insulin use less than 10 years and the patients understanding the hypothesis of this study, risks, expecting effects and agreeing this study.
We are checking oral GTT, insulin level, C-peptide level, HbA1C, etc. with some anthropometric measurs preoperatively, postoperatively, at 3 month and 12 month.
We will compare the clinical factors at each time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •type 2 diabetes
- •HbA1C > 7.0%
- •BMI 23 - 34 or BMI 21-22 with viceral obesity
- •insulin use less than 10 years
- •uncerstanding the risks, hypothesis, expecting effects
排除标准
- •type 1 diabetes
- •C-peptide < 1.0ng/ml
- •BMI < 21
- •severe cardiovascular diseases or their history
- •malignancy or history
- •alcoholics, pituitary failrue
- •history of severe ketosis, diabetic coma or precoma
- •abnormal liver enzyme, over 3 fold of normal level
- •liver cirrhosis or hepatitis
- •serum creatinine > 2.0mg/dL
- •glucocorticoids user
- •diabetes due to other endocrine diseases
- •pancreatic disease
- •anti-GAD Ab (+)
- •the incongruity for surgery
结局指标
主要结局
Hemoglobin A1C
时间窗: preoperatively, at 3month, at 12 month
change of the level
次要结局
- oral glucose tolerance test(preopertively, postoperatively, at 3 month, at 12 month)
研究者
Inha University Hospital
IRB Inha University Hospital
Inha University Hospital