Peripheral and Coronary Endothelial Dysfunction In Type 2diabetic Patients- Role of Metformin

Phase 3

Terminated

• Conditions: Coronary and Peripheral Endothelial Dysfunction

• Registration Number: NCT00169624
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Peripheral and coronary endothelial dysfunction in type 2 diabetic patients may be influenced by therapeutics. Using Radial flow monitoring and myocardial perfusion magnetic resonance imaging, we designed a controlled randomized double blind study to test the hypothesis that endothelial dysfunction will be reversed following 3 months of Metformin administration vs gliclazide. 30 patients will be included.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Study Start: 2005-10
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-04
• Last Update Posted: 2007-10-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

18-70 years old, type 2 diabetes, non significant coronary atherosclerosis on inclusion coronary angiogram (ie no coronary stenosis > 70%), HbA1c<9%

Read More

Exclusion Criteria

significant coronary stenosis (>70%), lack of informed consent, unstable hypertension, renal failure, contra-indication to metformin or gliclazide, pregnancy, atrial fibrillation, contraindication to MRI, or to adenosine, brachial artery calcifications

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Flow dependent and independent Brachial artery vasoreactivity assessed using Doppler technology at 3 month vs baseline

Secondary Outcome Measures

Name	Time	Method
Myocardial perfusion improvement following improved vasoreactivity assessed using myocardial perfusion imaging at 3 month vs baseline

Trial Locations

Locations (1)

Laurent SEBBAG; 🇫🇷 Lyon, France