Effect of Thiazolidinedione Treatment Vascular Risk Markers

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571506
• Other study ID #: 26963
• Status: Completed
• Phase: Phase 4
• First received: December 10, 2007
• Last updated: December 8, 2009
• Start date: May 2004
• Est. completion date: August 2007

Study information

• Verified date: December 2009
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Vascular Diseases

Intervention

Drug:
• Rosiglitazone
Rosiglitazone 4 mg tablets by mouth daily for 3 months
• Pioglitazone
Pioglitazone 30 mg tablet by mouth once daily

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	determine if treatment with rosiglitazone or pioglitazone affects platelet function as assessed by spontaneous and agonist-induced platelet aggregation		3 months	No
Secondary	adipocytokine concentrations (adiponectin, leptin), hemostatic parameters (fibrinogen, plasminogen activator inhibitor-1), high-sensitivity C-reactive protein		3 months	No