Evaluate the Effect of Exenatide Treatment on Coronary Artery Endothelial Function
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 主要终点
- Coronary endothelial function
研究概览
简要总结
Type 2 diabetes mellitus (T2DM) is an important risk factor of cardio-cerebral vascular disease such as coronary heart disease. GLP-1 is a kind of incretin secreted by the L-cell located in Ileum. It acts as an incretin hormone by protentiating glucose-stimulated insulin release. Recent studies reported that GLP-1 RA can protect the vascular endothelial and prevent vascular from atherosclerosis. Investigators design this study to investigate exenatide's effect on the improvement of the coronary endothelial function by evaluating endothelium dependent diastolic function and testing the vascular endothelial active substance and related inflammatory factors.
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
- •Females or males, and aged 20 to 65 years
- •Newly diagnose type 2 diabetes mellitus with BMI>25kg/m
- •HbA1C>8%.
排除标准
- •Type 1 diabetes mellitus, diabetic ketoacidosis, diabetic hyperosmolar coma.
- •Hepatic insufficiency (ALT or AST> 1.5*ULN).
- •Renal insufficiency [Creatinine clearance rate (Ccr)]<60ml/min estimated from MDRD equation).
- •Thyroid disease
- •Use of any anti-diabetic, anti-hypertension or anti-dyslipidemia drugs.
- •Pregnant or lactating woman.
- •Severe anemia.
- •Acute myocardial infarction or stoke.
- •Other conditions at investigator's discretion.
研究组 & 干预措施
Lifestyle intervention
干预措施: Byetta (Exenatide) (Drug)
Lifestyle intervention
干预措施: Glucophage ( Metformin Hydrochloride) (Drug)
结局指标
主要结局
Coronary endothelial function
时间窗: the change of coronary endothelial function(baseline, 12 weeks)
the change of coronary flow velocity reserve (CFVR)(baseline, 12 weeks)
次要结局
- the changes of fasting plasma glucose (FPG)(the changes of fasting plasma glucose (FPG)(baseline, 12 weeks))
- the changes of fasting serum insulin (FINS)(the changes of fasting serum insulin (FINS) (baseline, 12 weeks))
- the changes of IL-1B(the changes of IL-1B (baseline, 12 weeks))
- the changes of HbA1C(the changes of HbA1C(baseline, 12 weeks))
- the changes of TNF-α(the changes of TNF-α(baseline, 12 weeks))
- the changes of IL-6(the changes of IL-6 (baseline, 12 weeks))
研究者
Guang Wang
Director,Head of Endocrinology,Principal Investigator, Clinical Professor
Beijing Chao Yang Hospital