Study of Comparison the Treatment Effect Between Gastric Bypass and Exenatide in Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical events
研究概览
简要总结
Objectives: To investigate the treatment effect between Gastric Bypass and Exenatide in Type 2 Diabetes in our hospital, in order to investigate the possible mechanism of Gastric Bypass and Exenatide.
详细描述
Methods:
60 Type 2 diabetes in our hospital will divide into 3 groups: group A (20 patients who give basal treatment), group B (20 patients who give basal and Exenatide treatment, group C（20 patients who give basal and Gastric Bypass treatment). The age, height, weight, blood glucose, glycosylated hemoglobin A1c（HbA1c）,homeostasis model assessment(HOMA-IR), lipid, blood pressure, course of disease, ejection fraction (EF), fractional shortening(FS), diameter of left ventricle in late diastolic stage(LVEDd), the thickness of the ventricular septa（IVSD) and the posterior wall of the right ventricle in late diastolic stage (LVPWd) will record respectively. Left ventricular mass index (LVMI), relative wall thickness (RWT) will calculate and High-sensitive C-reactive protein (HsCRP), adiponectin and Tumor necrosis factor-α（TNF-α） will detect as Baseline. After each group's treatment, Change from baseline of all indexes will record, Multifactor logistic regression will be analyzed the correlations between each positive indexes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥ 35kg/m2, With Type 2 Diabetes;
- •BMI32-34.9kg/m2, With Type 2 Diabetes, Insulin Therapy in Combination With Oral Administration of Drugs for 6 Months and HbA1c ≥ 7%;
- •Between the Ages of 18-60 Years;
- •Course of Type 2 Diabetes ≤ 5 Years;
- •ICA, IAA, GAD Are Negative , C-peptide Level is Not Less Than 0.3mg / L;
排除标准
- •non-diabetic patients , type 1 diabetes (serum insulin antibodies (ICA) or glutamic acid decarboxylase antibodies (GADA)-positive autoimmune diabetes), special type of diabetes, gestational diabetes;
- •patients who had liver or renal failure
- •severe infections in patients and patients who had cerebrovascular disease
- •patients who had heart failure
- •fasting serum insulin or 2-hour postprandial serum insulin were lower than normal (<20mmol / L)
- •course of diabetes> 5 years or age> 60 years or age <18 years
研究组 & 干预措施
Gastric Bypass
basal treatment and Gastric Bypass
干预措施: Gastric Bypass (Procedure)
Exenatide
basal treatment and Exenatide
干预措施: Exenatide (Drug)
结局指标
主要结局
Clinical events
时间窗: 1 year
Participant with stroke or Myocardial infarction or acute diabetic complication or Liver and renal failure or death or other Adverse Events.
次要结局
- Blood testing(1 year)
- Blood pressure monitoring(1 month)
- echocardiography(1 year)
研究者
Wu Qinan
Third Military Medical University
Third Military Medical University