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

This study has been terminated.

First Received on September 9, 2005. Last Updated on October 4, 2007 History of Changes

Sponsor:	Hospices Civils de Lyon
Information provided by:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT00169624

Purpose

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	Intervention	Phase
Coronary and Peripheral Endothelial Dysfunction	Drug: Metformin Drug: Gliclazide	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double-Blind
Official Title:	The DIAMET Study: Peripheral and Coronary Endothelial Dysfunction in Type 2diabetic Patients- Evaluation of Reversibility Following 3 Months of Metformin Treatment

Resource links provided by NLM:

Drug Information available for: Gliclazide Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

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

Estimated Enrollment:	30
Study Start Date:	October 2005

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169624

Locations

France
Laurent SEBBAG
Lyon, France, 69677

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Laurent SEBBAG, MD

Hospices Civils de Lyon

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00169624 History of Changes
Other Study ID Numbers:	2004.346
Study First Received:	September 9, 2005
Last Updated:	October 4, 2007
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Hospices Civils de Lyon:

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

Additional relevant MeSH terms:

Gliclazide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012