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

NCT00549874 | Completed DMC

• 1 other identifier: SKB 276
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes

Keywords

insulin resistance; type 2 diabetes; myocardial perfusion; nitrosative stress; thiazolidinediones

Outcome Measures

Primary Outcomes (1)

• Myocardial blood flow regulation

  6 months intervention

Secondary Outcomes (1)

• biomarkers of oxidative/nitrosative stress

  6 month intervention

Study Arms (2)

1

EXPERIMENTAL

Drug: Rosiglitazone

2

EXPERIMENTAL

Drug: Glyburide

Interventions

Rosiglitazone DRUG

oral 8 mg/once daily for 6 months

1

Glyburide DRUG

20 mg/ once daily for 6 months

2

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• GlaxoSmithKline: collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Toledo - Health Campus

Toledo, Ohio, 43606, United States

Location

Related Publications (1)

• Pop-Busui R, Oral E, Raffel D, Byun J, Bajirovic V, Vivekanandan-Giri A, Kellogg A, Pennathur S, Stevens MJ. Impact of rosiglitazone and glyburide on nitrosative stress and myocardial blood flow regulation in type 2 diabetes mellitus. Metabolism. 2009 Jul;58(7):989-94. doi: 10.1016/j.metabol.2009.02.020.

  PMID: 19394661 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Rosiglitazone; Glyburide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfonylurea Compounds; Urea; Amides; Sulfones

Study Officials

• Martin Stevens, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 24, 2007
• First Posted: October 26, 2007
• Study Start: February 1, 2002
• Study Completion: November 1, 2006
• Last Updated: November 9, 2007

Record last verified: 2007-10

Locations

US (2)