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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00169624
Recruitment Status : Terminated
First Posted : September 15, 2005
Last Update Posted : October 5, 2007
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Coronary and Peripheral Endothelial Dysfunction Drug: Metformin Drug: Gliclazide Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
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 : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Flow dependent and independent Brachial artery vasoreactivity assessed using Doppler technology at 3 month vs baseline

Secondary Outcome Measures :
  1. Myocardial perfusion improvement following improved vasoreactivity assessed using myocardial perfusion imaging at 3 month vs baseline

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00169624

Laurent SEBBAG
Lyon, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Laurent SEBBAG, MD Hospices Civils de Lyon Identifier: NCT00169624     History of Changes
Other Study ID Numbers: 2004.346
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: October 5, 2007
Last Verified: October 2007

Keywords provided by Hospices Civils de Lyon:
coronary endothelial dysfunction,

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs