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

Condition(s) targeted: Coronary and Peripheral Endothelial Dysfunction

Intervention: Metformin (Drug); Gliclazide (Drug)

Phase: Phase 3

Status: No longer recruiting

Sponsored by: Hospices Civils de Lyon

Official(s) and/or principal investigator(s):
Laurent SEBBAG, MD, Principal Investigator, Affiliation: Hospices Civils de Lyon

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.

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

Study design: Interventional, Randomized, Double-Blind, Placebo Control, Crossover Assignment

Primary outcome: Flow dependent and independent Brachial artery vasoreactivity assessed using Doppler technology at 3 month vs baseline

Secondary outcome: Myocardial perfusion improvement following improved vasoreactivity assessed using myocardial perfusion imaging at 3 month vs baseline

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Laurent SEBBAG, Lyon 69677, France

Starting date: October 2005
Last updated: March 7, 2007