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| Sponsor: | University of Michigan |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | University of Michigan |
| ClinicalTrials.gov Identifier: | NCT00549874 |
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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | Martin Stevens, MD, PhD | University of Michigan |
More Information
| 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 |
|
insulin resistance type 2 diabetes myocardial perfusion nitrosative stress thiazolidinediones |
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Rosiglitazone Glyburide Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |