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Effect of Thiazolidinedione Treatment Vascular Risk Markers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00571506
Recruitment Status : Completed
First Posted : December 12, 2007
Last Update Posted : December 9, 2009
Information provided by:
University of Arkansas

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Vascular Diseases Drug: Rosiglitazone Drug: Pioglitazone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Determine the Effects of Short-term Thiazolidinedione Treatment on Vascular Risk Markers in Type 2 Diabetes Patients
Study Start Date : May 2004
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Rosiglitazone 4 mg by mouth daily
Drug: Rosiglitazone
Rosiglitazone 4 mg tablets by mouth daily for 3 months
Other Name: Avandia

Active Comparator: 2
Pioglitazone 30 mg by mouth daily
Drug: Pioglitazone
Pioglitazone 30 mg tablet by mouth once daily
Other Name: Actos

Primary Outcome Measures :
  1. determine if treatment with rosiglitazone or pioglitazone affects platelet function as assessed by spontaneous and agonist-induced platelet aggregation [ Time Frame: 3 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00571506

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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
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Principal Investigator: Amy M. Franks, Pharm.D. University of Arkansas

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Responsible Party: Amy M. Franks, Pharm.D., University of Arkansas for Medical Sciences College of Pharmacy Identifier: NCT00571506     History of Changes
Other Study ID Numbers: 26963
First Posted: December 12, 2007    Key Record Dates
Last Update Posted: December 9, 2009
Last Verified: December 2009
Keywords provided by University of Arkansas:
Diabetes Mellitus, Type 2
Vascular Diseases
Platelet Aggregation
Additional relevant MeSH terms:
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Vascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Hypoglycemic Agents
Physiological Effects of Drugs