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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00549874
First Posted: October 26, 2007
Last Update Posted: November 9, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by:
University of Michigan
  Purpose
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 Intervention
Type 2 Diabetes Drug: Rosiglitazone Drug: Glyburide

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Myocardial blood flow regulation [ Time Frame: 6 months intervention ]

Secondary Outcome Measures:
  • biomarkers of oxidative/nitrosative stress [ Time Frame: 6 month intervention ]

Enrollment: 27
Study Start Date: February 2002
Study Completion Date: November 2006
Arms Assigned Interventions
Experimental: 1 Drug: Rosiglitazone
oral 8 mg/once daily for 6 months
Experimental: 2 Drug: Glyburide
20 mg/ once daily for 6 months

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00549874


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Ohio
University of Toledo - Health Campus
Toledo, Ohio, United States, 43606
Sponsors and Collaborators
University of Michigan
GlaxoSmithKline
Investigators
Principal Investigator: Martin Stevens, MD, PhD University of Michigan
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00549874     History of Changes
Other Study ID Numbers: SKB 276
First Submitted: October 24, 2007
First Posted: October 26, 2007
Last Update Posted: November 9, 2007
Last Verified: October 2007

Keywords provided by University of Michigan:
insulin resistance
type 2 diabetes
myocardial perfusion
nitrosative stress
thiazolidinediones

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs