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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549874
• Other study ID #: SKB 276
• Status: Completed
• Phase: N/A
• First received: October 24, 2007
• Last updated: November 8, 2007
• Start date: February 2002
• Est. completion date: November 2006

Study information

• Verified date: October 2007
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Toledo - Health Campus	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myocardial blood flow regulation		6 months intervention
Secondary	biomarkers of oxidative/nitrosative stress		6 month intervention