Evaluate the Effect of Exenatide Treatment on Coronary Artery Endothelial Function
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 100
- Primary Endpoint
- Coronary endothelial function
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Females or males, and aged 20 to 65 years
- •Newly diagnose type 2 diabetes mellitus with BMI>25kg/m
- •HbA1C>8%.
Exclusion Criteria
- •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.
Arms & Interventions
Lifestyle intervention
Intervention: Byetta (Exenatide) (Drug)
Lifestyle intervention
Intervention: Glucophage ( Metformin Hydrochloride) (Drug)
Outcomes
Primary Outcomes
Coronary endothelial function
Time Frame: the change of coronary endothelial function(baseline, 12 weeks)
the change of coronary flow velocity reserve (CFVR)(baseline, 12 weeks)
Secondary Outcomes
- 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))
Investigators
Guang Wang
Director,Head of Endocrinology,Principal Investigator, Clinical Professor
Beijing Chao Yang Hospital