Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00549874
First received: October 24, 2007
Last updated: November 8, 2007
Last verified: October 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Michigan

Additional 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
Study First Received: October 24, 2007
Last Updated: November 8, 2007
Health Authority: United States: Institutional Review Board

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Rosiglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014