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

Phase 3TerminatedNCT00169624

Hospices Civils de Lyon30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Coronary and Peripheral Endothelial Dysfunction

Interventions

MetforminDRUG

GliclazideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Laurent SEBBAG

Lyon, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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