Effect of Thiazolidinedione Treatment Vascular Risk Markers

University of Arkansas

Status and phase

Completed

Phase 4

Conditions

Diabetes Mellitus, Type 2

Vascular Diseases

Treatments

Drug: Rosiglitazone

Drug: Pioglitazone

Study type

Interventional

Funder types

Other

Identifiers

NCT00571506

26963

Details and patient eligibility

About

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.

Full description

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.

Enrollment

25 patients

Sex

All

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Men and women of all races
Age 40-65 years
Diagnosis of type 2 diabetes
hemoglobin A1C ≥ 7%
eligible whether or not currently taking antihyperglycemic medications

Exclusion criteria

History of rosiglitazone or pioglitazone use in the previous 3 months
Known diagnosis of peripheral vascular disease or cardiac failure
Recent history (within past 6 months) of ischemic stroke, myocardial infarction, percutaneous coronary intervention, or coronary artery bypass surgery
Active liver disease or elevated serum transaminases (ALT >2.5x upper limit of normal)
Current therapy with oral anticoagulants (warfarin, heparin, low molecular weight heparin), clopidogrel, or immunosuppressive agents
Pregnancy or breastfeeding
Any other condition, in the opinion of the investigator, that renders the subject unable to complete the study, that interferes with optimal participation in the study, or that produces significant risk to the subject