Effect of Thiazolidinedione Treatment Vascular Risk Markers

December 8, 2009 updated by: University of Arkansas

A Pilot Study to Determine the Effects of Short-term Thiazolidinedione Treatment on Vascular Risk Markers in Type 2 Diabetes Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Rosiglitazone 4 mg by mouth daily
Drug: Rosiglitazone
Rosiglitazone 4 mg tablets by mouth daily for 3 months
Other Names:
  • Avandia
Active Comparator: 2
Pioglitazone 30 mg by mouth daily
Drug: Pioglitazone
Pioglitazone 30 mg tablet by mouth once daily
Other Names:
  • Actos

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
determine if treatment with rosiglitazone or pioglitazone affects platelet function as assessed by spontaneous and agonist-induced platelet aggregation
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
adipocytokine concentrations (adiponectin, leptin), hemostatic parameters (fibrinogen, plasminogen activator inhibitor-1), high-sensitivity C-reactive protein
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Investigators

  • Principal Investigator: Amy M. Franks, Pharm.D., University of Arkansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

December 10, 2007

First Submitted That Met QC Criteria

December 11, 2007

First Posted (Estimate)

December 12, 2007

Study Record Updates

Last Update Posted (Estimate)

December 9, 2009

Last Update Submitted That Met QC Criteria

December 8, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26963

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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