- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00169624
Peripheral and Coronary Endothelial Dysfunction In Type 2diabetic Patients- Role of Metformin
The DIAMET Study: Peripheral and Coronary Endothelial Dysfunction in Type 2diabetic Patients- Evaluation of Reversibility Following 3 Months of Metformin Treatment
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Lyon, France, 69677
- Laurent Sebbag
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Flow dependent and independent Brachial artery vasoreactivity assessed using Doppler technology at 3 month vs baseline
|
Secondary Outcome Measures
Outcome Measure |
---|
Myocardial perfusion improvement following improved vasoreactivity assessed using myocardial perfusion imaging at 3 month vs baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004.346
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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