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Clinical Trials/NCT02584075
NCT02584075UnknownPhase 4

Evaluate the Effect of Exenatide Treatment on Coronary Artery Endothelial Function

Beijing Chao Yang Hospital0 sites100 target enrollmentStarted: November 2015Last updated:
Conditions
Interventions
Drugs

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

Experimental

Intervention: Byetta (Exenatide) (Drug)

Lifestyle intervention

Experimental

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

Sponsor
Beijing Chao Yang Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Guang Wang

Director,Head of Endocrinology,Principal Investigator, Clinical Professor

Beijing Chao Yang Hospital

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