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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014