Official Title: “Effect of Rosiglitazone on Myocardial Blood Flow Regulation in Type 2 Diabetes”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Uncontrolled, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Rosiglitazone
  • oral 8 mg/once daily for 6 months
• Drug: Glyburide
  • 20 mg/ once daily for 6 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2

Primary Measures

• Myocardial blood flow regulation
  • Time Frame: 6 months intervention
    

Secondary Measures

• biomarkers of oxidative/nitrosative stress
  • Time Frame: 6 month intervention
    

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.
• Patients with a history of "severe hypoglycemia" which required the assistance of a third party or ketoacidosis requiring hospital admission within the last 3 months.
• Patients with lung disease for example resulting from chronic obstructive airways disease.
• Patients with abnormal thyroid function tests.
• Patients having taken other systemic investigational drugs (especially for neuropathy) or initiating a new or experimental insulin delivery device within 3 months of starting the study.
• Patients with a history of allergic reactions to multiple drugs or biological products.
• Obese patients (BMI greater than 35).
• Patients who refuse to sign the informed consent.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Michigan

Overall Clinical Trial Officials and Contacts

Martin Stevens, MD, PhD Principal Investigator University of Michigan  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00549874

Study ID Number: SKB 276

ClinicalTrials.gov Identifier: NCT00549874

Health Authority: United States: Institutional Review Board