Effect of Thiazolidinedione Treatment Vascular Risk Markers
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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 |
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| United States, Arkansas | |
| University of Arkansas for Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| 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 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Cardiovascular Diseases |
Pioglitazone Rosiglitazone 2,4-thiazolidinedione Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013