Evaluate the Effect of Exenatide Treatment on Coronary Artery Endothelial Function

NCT ID: NCT02584075

Last Updated: 2015-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-01-31

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.

Conditions

Coronary Endothelial Function

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lifestyle intervention

Group Type: EXPERIMENTAL

Byetta (Exenatide)

Intervention Type: DRUG

Exenatide treatment: 5 µg twice/day subcutaneous injection for 4 weeks, 10 µg twice/day subcutaneous injection for 8 weeks.

Glucophage ( Metformin Hydrochloride)

Intervention Type: DRUG

Metformin 500mg Tid

Interventions

Byetta (Exenatide)

Exenatide treatment: 5 µg twice/day subcutaneous injection for 4 weeks, 10 µg twice/day subcutaneous injection for 8 weeks.

Intervention Type: DRUG

Glucophage ( Metformin Hydrochloride)

Metformin 500mg Tid

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Chao Yang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guang Wang

Director,Head of Endocrinology,Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Exen100

Identifier Type: -

Identifier Source: org_study_id