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Evaluate the Effect of Exenatide Treatment on Coronary Artery Endothelial Function

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ClinicalTrials.gov Identifier: NCT02584075
Recruitment Status : Unknown
Verified October 2015 by Guang Wang, Beijing Chao Yang Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 22, 2015
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):
Guang Wang, 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.

Condition or disease Intervention/treatment Phase
Coronary Endothelial Function Drug: Byetta (Exenatide) Drug: Glucophage ( Metformin Hydrochloride) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lifestyle intervention Drug: Byetta (Exenatide)
Exenatide treatment: 5 µg twice/day subcutaneous injection for 4 weeks, 10 µg twice/day subcutaneous injection for 8 weeks.

Drug: Glucophage ( Metformin Hydrochloride)
Metformin 500mg Tid




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. the changes of fasting plasma glucose (FPG) [ Time Frame: the changes of fasting plasma glucose (FPG)(baseline, 12 weeks) ]
    the changes of fasting plasma glucose (FPG) (baseline, 12 weeks)

  2. the changes of HbA1C [ Time Frame: the changes of HbA1C(baseline, 12 weeks) ]
    the changes of HbA1C (baseline, 12 weeks)

  3. the changes of fasting serum insulin (FINS) [ Time Frame: the changes of fasting serum insulin (FINS) (baseline, 12 weeks) ]
    the changes of fasting serum insulin (FINS) (baseline, 12 weeks)

  4. the changes of IL-1B [ Time Frame: the changes of IL-1B (baseline, 12 weeks) ]
    the changes of IL-1B (baseline, 12 weeks)

  5. the changes of IL-6 [ Time Frame: the changes of IL-6 (baseline, 12 weeks) ]
    the changes of IL-6 (baseline, 12 weeks)

  6. the changes of TNF-α [ Time Frame: the changes of TNF-α(baseline, 12 weeks) ]
    the changes of TNF-α(baseline, 12 weeks)



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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Responsible Party: Guang Wang, Director,Head of Endocrinology,Principal Investigator, Clinical Professor, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT02584075    
Other Study ID Numbers: Exen100
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Metformin
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists