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Evaluate the Effect of Exenatide Treatment on Coronary Artery Endothelial Function

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Capital Medical University

Status and phase

Unknown
Phase 4

Conditions

Coronary Endothelial Function

Treatments

Drug: Glucophage ( Metformin Hydrochloride)
Drug: Byetta (Exenatide)

Study type

Interventional

Funder types

Other

Identifiers

NCT02584075
Exen100

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Lifestyle intervention
Experimental group
Treatment:
Drug: Glucophage ( Metformin Hydrochloride)
Drug: Byetta (Exenatide)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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