Effect of Rosiglitazone on Myocardial Blood Flow Regulation in Type 2 Diabetes
Information source: University of Michigan
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: Rosiglitazone (Drug); Glyburide (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Michigan Official(s) and/or principal investigator(s):
Martin Stevens, MD, PhD, Principal Investigator, Affiliation: University of Michigan
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.
Clinical Details
Official title: Effect of Rosiglitazone on Myocardial Blood Flow Regulation in Type 2 Diabetes
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Uncontrolled, Parallel Assignment, Efficacy Study
Primary outcome: Myocardial blood flow regulation
Secondary outcome: biomarkers of oxidative/nitrosative stress
Eligibility
Minimum age: 30 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
- 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.
Locations and Contacts
University of Michigan, Ann Arbor, Michigan 48109, United States
University of Toledo - Health Campus, Toledo, Ohio 43606, United States
Additional Information
Starting date: February 2002
Ending date: November 2006
Last updated: November 8, 2007
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