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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Brief Summary

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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

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Conditions

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Coronary and Peripheral Endothelial Dysfunction

Keywords

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Diabetes, coronary endothelial dysfunction, metformin, glyclazide, MRI.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Interventions

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Metformin

Intervention Type DRUG

Gliclazide

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Laurent SEBBAG, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Laurent SEBBAG

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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2004.346

Identifier Type: -

Identifier Source: org_study_id