Evaluate the Effect of Exenatide Treatment on Coronary Artery Endothelial Function

NCT02584075 | Unknown Phase 4

• 1 other identifier: Exen100
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Coronary endothelial function

  the change of coronary flow velocity reserve (CFVR)(baseline, 12 weeks)

  the change of coronary endothelial function(baseline, 12 weeks)

Secondary Outcomes (6)

• the changes of fasting plasma glucose (FPG)

  the changes of fasting plasma glucose (FPG)(baseline, 12 weeks)

• the changes of HbA1C

  the changes of HbA1C(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 IL-6

  the changes of IL-6 (baseline, 12 weeks)

Study Arms (1)

Lifestyle intervention

EXPERIMENTAL

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

Interventions

Byetta (Exenatide) DRUG

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

Lifestyle intervention

Glucophage ( Metformin Hydrochloride) DRUG

Metformin 500mg Tid

Lifestyle intervention

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females or males, and aged 20 to 65 years
• Newly diagnose type 2 diabetes mellitus with BMI\>25kg/m2.
• HbA1C\>8%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

MeSH Terms

Interventions

Exenatide; Metformin

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director,Head of Endocrinology,Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 22, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: January 1, 2018
• Last Updated: October 22, 2015

Record last verified: 2015-10