The purpose of this study is to examine the effects of two diabetes medications, rosiglitazone and pioglitazone, on markers of vascular disease in subjects with type 2 diabetes.
Diabetes is a common disease in the United States, affecting over 10 million Americans. Vascular disease, including heart attack and stroke, affects many diabetic patients and will cause the death of three-fourths of these patients. Because the majority of diabetic patients will suffer complications or death from vascular disease, we will explore treatments that have the potential to reduce or prevent vascular disease in type 2 diabetes patients. Our study will examine the effects of two diabetes medications, rosiglitazone (ROSI) and pioglitazone (PIO), on markers of vascular disease in 20 subjects with type 2 diabetes. It is thought that these two medications will reduce the risk of vascular disease by affecting the platelets and proteins that that regulate the processes involved in clot formation. One-half of the subjects enrolled in our study will take ROSI and the other half will take PIO. We will measure the clumping ability of these subjects' platelets before, during, and after three months of treatment with ROSI or PIO. We will measure the blood concentrations of several proteins (fibrinogen, PAI-1, CRP, adiponectin, and leptin) before and after treatment with the study drugs. These experiments will give us information about any beneficial effects of ROSI and PIO on the clot-forming ability in diabetes patients. We expect that treatment with ROSI and PIO will result in improvement of the disturbed clot-forming processes that predispose diabetic patients to vascular disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Rosiglitazone 4 mg tablets by mouth daily for 3 months
Pioglitazone 30 mg tablet by mouth once daily
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
determine if treatment with rosiglitazone or pioglitazone affects platelet function as assessed by spontaneous and agonist-induced platelet aggregation
Time frame: 3 months
adipocytokine concentrations (adiponectin, leptin), hemostatic parameters (fibrinogen, plasminogen activator inhibitor-1), high-sensitivity C-reactive protein
Time frame: 3 months
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