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

This study has been terminated.
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00169624
First received: September 9, 2005
Last updated: October 4, 2007
Last verified: October 2007
History of Changes
  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 3

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:

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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 May 16, 2013