Effect of Thiazolidinedione Treatment Vascular Risk Markers

This study has been completed.
Sponsor:
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00571506
First received: December 10, 2007
Last updated: December 8, 2009
Last verified: December 2009
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
Vascular Diseases
Drug: Rosiglitazone
Drug: Pioglitazone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • determine if treatment with rosiglitazone or pioglitazone affects platelet function as assessed by spontaneous and agonist-induced platelet aggregation [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adipocytokine concentrations (adiponectin, leptin), hemostatic parameters (fibrinogen, plasminogen activator inhibitor-1), high-sensitivity C-reactive protein [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: May 2004
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571506

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

No publications provided

Responsible Party: Amy M. Franks, Pharm.D., University of Arkansas for Medical Sciences College of Pharmacy
ClinicalTrials.gov Identifier: NCT00571506     History of Changes
Other Study ID Numbers: 26963
Study First Received: December 10, 2007
Last Updated: December 8, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
Diabetes Mellitus, Type 2
Vascular Diseases
Thiazolidinediones
Platelet Aggregation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Vascular Diseases
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
2,4-thiazolidinedione
Pioglitazone
Rosiglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014