Evaluate the Effect of Exenatide Treatment on Coronary Artery Endothelial Function

Phase 4

• Conditions: Coronary Endothelial Function
• Interventions: Drug: Byetta (Exenatide); Drug: Glucophage ( Metformin Hydrochloride)

• Registration Number: NCT02584075
• Lead Sponsor: Beijing Chao Yang Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-10
• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2015-10-21
• Last Update Submitted: 2015-10-21
• Study First Posted: 2015-10-22
• Last Update Posted: 2015-10-22
• Study Start: 2015-11
• Primary Completion: 2017-11
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lifestyle intervention	Byetta (Exenatide)	-
Lifestyle intervention	Glucophage ( Metformin Hydrochloride)	-

Primary Outcome Measures

Name	Time	Method
Coronary endothelial function	the change of coronary endothelial function(baseline, 12 weeks)	the change of coronary flow velocity reserve (CFVR)(baseline, 12 weeks)

Secondary Outcome Measures

Name	Time	Method
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 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 IL-1B	the changes of IL-1B (baseline, 12 weeks)	the changes of IL-1B (baseline, 12 weeks)
the changes of HbA1C	the changes of HbA1C(baseline, 12 weeks)	the changes of HbA1C (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-6	the changes of IL-6 (baseline, 12 weeks)	the changes of IL-6 (baseline, 12 weeks)