Taiwan Diabesity Study:Comparison With Mild Obese T2DM Patients Who Under Metabolic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Evaluate the natural course of the diabetes of obese patients over a period of 10 years
研究概览
简要总结
T2DM has become a major health burden for our society. More and more data support the relative effectiveness of gastrointestinal metabolic surgery, known as bariatric surgery, in the remission of T2DM of BMI less35. The metabolic surgery guidelines of IDF recommend BMI over 27.5 in Asia.
The evidence reviewed above strongly points to the need for a large randomized, controlled trial to evaluate the risks and benefits of obesity surgery in the treatment of type 2 diabetes Mellitus. This study is expected to provide very significant findings about the natural course of diabetes in obese diabetic patients.
详细描述
This study will recruit 200 obese T2DM patients at MSGH, for a total of 1000 in Taiwan. The inclusion criteria are those with T2DM more than 6 months, under medical management in diabetes center, BMI over 25, age between 20 and 67 years. The goals of this study are to evaluate the nature course of the diabetes for 10 years. The primary outcomes for the treatment will be assessed every year after intervention and will be composite of CVD risk factor; specifically, the proportion of patients with HbA1c < 7%, LDL cholesterol < 100 mg/dl and systolic blood pressure < 140 mmHg.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diabetic Mellitus Type 2 medically controlled at Diabetes Center for at least six months
- •BMI over 25
- •age between 20 and 67
排除标准
- •Diagnosed with cancer within past five years
- •HIV positive
- •Active TB patients
- •CV events in past six months
- •serum cretinine over 2.0 mg/dl
- •C-peptide bellow 1.0 ng/ml in past three months
- •Diabetic retinopathy; vision bellow 0.1
- •Cushing's syndrome
- •History of organ transplant
- •History of bariatric surgery
- •History of alcohol or drug dependency in past five years
- •Psychological problems likely to interfere with adherence to protocol
结局指标
主要结局
Evaluate the natural course of the diabetes of obese patients over a period of 10 years
时间窗: ten years
次要结局
未报告次要终点
研究者
WEI-CHENG YAO
Professor
Min-Sheng General Hospital