Effect of Rosiglitazone on Myocardial Blood Flow Regulation in Type 2 Diabetes
Overview
- Phase
- Not Applicable
- Intervention
- Rosiglitazone
- Conditions
- Type 2 Diabetes
- Sponsor
- University of Michigan
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- Myocardial blood flow regulation
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
The overall hypothesis to be tested is that increased insulin resistance contributes to abnormal cardiac blood flow regulation in type 2 diabetic patients, which can be reversed by 6 months treatment with rosiglitazone. The planned experimental approach will be to utilize nuclear medicine techniques to evaluate whether the administration of rosiglitazone for 6 months can reverse regional deficits in myocardial blood flow and glucose utilization in type 2 diabetes in a randomized double blind controlled study. These studies will help elucidate the potential of rosiglitazone to correct deficits of myocardial blood flow complicating diabetes with the overall aim being the eventual prevention of sudden cardiac death.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type 2 diabetes
- •30-75 years of age
- •less than 1% fluctuation in HbA1c over 3 months
- •women must be on contraception
- •HbA1c 6-9%
- •willingness to sign approved consent form
Exclusion Criteria
- •Nursing mothers, pregnant women (excluded by a negative pregnancy test).
- •Subjects requiring insulin therapy (\>20 units/day) and can not be converted to sulfonylurea therapy without loss of diabetes control.
- •Patients with a history of drug or alcohol dependence in the last 5 years
- •Patients with pre-existing cardiovascular disease including coronary artery disease, heart attack, heart failure, abnormal heart rhythms, structural abnormalities and valve disease, peripheral vascular disease and uncontrolled high blood pressure.
- •Patients with a history of high cholesterol requiring therapy.
- •Patients with severe systemic disease other than diabetes which has as a recognized complication neuropathy
- •Patients currently taking drugs which act on the blood vessels (for example for hypertension)
- •Patients taking antidepressants, or other drugs or medications known to interfere with the uptake or metabolism of catecholamines (stress hormones)
- •Patients with poor renal function or have significant liver disease
- •Patients with a history of previous kidney, pancreas or cardiac transplantation.
Arms & Interventions
1
Intervention: Rosiglitazone
2
Intervention: Glyburide
Outcomes
Primary Outcomes
Myocardial blood flow regulation
Time Frame: 6 months intervention
Secondary Outcomes
- biomarkers of oxidative/nitrosative stress(6 month intervention)