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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Terminated

CT.gov ID

NCT00169624

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary and Peripheral Endothelial Dysfunction	Drug: Metformin Drug: Gliclazide	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Official Title:

The DIAMET Study: Peripheral and Coronary Endothelial Dysfunction in Type 2diabetic Patients- Evaluation of Reversibility Following 3 Months of Metformin Treatment

Study Start Date :

Oct 1, 2005

Outcome Measures

Primary Outcome Measures

Flow dependent and independent Brachial artery vasoreactivity assessed using Doppler technology at 3 month vs baseline []

Secondary Outcome Measures

Myocardial perfusion improvement following improved vasoreactivity assessed using myocardial perfusion imaging at 3 month vs baseline []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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