Coronary Endothelial Function
Conditions
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.
Interventions
Exenatide treatment: 5 µg twice/day subcutaneous injection for 4 weeks, 10 µg twice/day subcutaneous injection for 8 weeks.
DRUGGlucophage ( Metformin Hydrochloride)
Metformin 500mg Tid
Sponsors
Beijing Chao Yang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Females or males, and aged 20 to 65 years * Newly diagnose type 2 diabetes mellitus with BMI\>25kg/m2. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coronary endothelial function | the change of coronary endothelial function(baseline, 12 weeks) | the change of coronary flow velocity reserve (CFVR)(baseline, 12 weeks) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the changes of HbA1C | the changes of HbA1C(baseline, 12 weeks) | the changes of HbA1C (baseline, 12 weeks) |
| the changes of fasting serum insulin (FINS) | the changes of fasting serum insulin (FINS) (baseline, 12 weeks) | the changes of fasting serum insulin (FINS) (baseline, 12 weeks) |
| the changes of fasting plasma glucose (FPG) | the changes of fasting plasma glucose (FPG)(baseline, 12 weeks) | the changes of fasting plasma glucose (FPG) (baseline, 12 weeks) |
| the changes of IL-6 | the changes of IL-6 (baseline, 12 weeks) | the changes of IL-6 (baseline, 12 weeks) |
| the changes of TNF-α | the changes of TNF-α(baseline, 12 weeks) | the changes of TNF-α(baseline, 12 weeks) |
| the changes of IL-1B | the changes of IL-1B (baseline, 12 weeks) | the changes of IL-1B (baseline, 12 weeks) |
Outcome results
None listed