Effect of Thiazolidinedione Treatment Vascular Risk Markers

NCT ID: NCT00571506

Last Updated: 2009-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2007-08-31

Brief Summary

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.

Detailed 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.

Conditions

Diabetes Mellitus, Type 2; Vascular Diseases

Keywords

Diabetes Mellitus, Type 2; Vascular Diseases; Thiazolidinediones; Platelet Aggregation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Rosiglitazone 4 mg by mouth daily

Group Type: EXPERIMENTAL

Rosiglitazone

Intervention Type: DRUG

Rosiglitazone 4 mg tablets by mouth daily for 3 months

2

Pioglitazone 30 mg by mouth daily

Group Type: ACTIVE_COMPARATOR

Pioglitazone

Intervention Type: DRUG

Pioglitazone 30 mg tablet by mouth once daily

Interventions

Rosiglitazone

Rosiglitazone 4 mg tablets by mouth daily for 3 months

Intervention Type: DRUG

Pioglitazone

Pioglitazone 30 mg tablet by mouth once daily

Intervention Type: DRUG

Other Intervention Names

Avandia; Actos

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

University of Arkansas for Medical Sciences College of Pharmacy

Principal Investigators

Amy M. Franks, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

26963

Identifier Type: -

Identifier Source: org_study_id