Effect of Rosiglitazone on Myocardial Blood Flow Regulation in Type 2 Diabetes

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT00549874

Collaborator

GlaxoSmithKline (Industry)

Enrollment

Locations

Arms

Duration (Months)

13.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: Rosiglitazone Drug: Glyburide	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Rosiglitazone on Myocardial Blood Flow Regulation in Type 2 Diabetes

Study Start Date :

Feb 1, 2002

Actual Study Completion Date :

Nov 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Rosiglitazone oral 8 mg/once daily for 6 months
Experimental: 2	Drug: Glyburide 20 mg/ once daily for 6 months

Arm

Intervention/Treatment

Experimental: 1

Drug: Rosiglitazone

oral 8 mg/once daily for 6 months

Experimental: 2

Drug: Glyburide

20 mg/ once daily for 6 months

Outcome Measures

Primary Outcome Measures

Myocardial blood flow regulation [6 months intervention]

Secondary Outcome Measures

biomarkers of oxidative/nitrosative stress [6 month intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.