Coronary and Peripheral Endothelial Dysfunction
Conditions
Keywords
Diabetes,, coronary endothelial dysfunction,, metformin,, glyclazide,, MRI.
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.
Interventions
DRUGMetformin
DRUGGliclazide
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Flow dependent and independent Brachial artery vasoreactivity assessed using Doppler technology at 3 month vs baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Myocardial perfusion improvement following improved vasoreactivity assessed using myocardial perfusion imaging at 3 month vs baseline | — |
Countries
France
Outcome results
None listed