TART - Troglitazone Atherosclerosis Regression Trial
The purpose of this study is to determine if troglitazone reduces the progression of early preintrusive carotid atherosclerosis in insulin-requiring diabetes patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||TART - Troglitazone Atherosclerosis Regression Trial|
- rate of change of the right distal common carotid artery far wall intima-media thickness (IMT) measured every 6 months
- flow mediated brachial artery vasoactivity
- carbohydrate and lipid metabolism
|Study Start Date:||January 1997|
|Study Completion Date:||April 2000|
|Primary Completion Date:||April 2000 (Final data collection date for primary outcome measure)|
Insulin resistance and hyperinsulinism appear to be important risk factors for the development of atherosclerosis in diabetes patients. The atherogenic potential of insulin has been shown to improve cholesterol and may have an effect on the thickness and structure of the arterial wall. Troglitazone is an oral diabetic agent that treats insulin resistance. Based on the initial data available, it would appear that troglitazone may be effective in both glycemic control and improved atherosclerosis risk in diabetes patients. This study will compare the effects of troglitazone to placebo in insulin-requiring diabetes patients on both glycemic control and progression of atherosclerosis.
A total of 288 men and women 30 to 70 years of age with insulin-treated diabetes were recruited and entered an 8 week run-in phase to stabilize diet, exercise, insulin dose and glucose levels. Upon successful completion of the run-in phase, all patients were randomized into one of two groups to receive either troglitazone 400mg/day or a matching placebo while continuing with diet and exercise regimens and insulin dose to maintain pre-meal glucose levels between 100 to 150 mg/dL.
Follow up visits occurred every 2 weeks for 2 months, every 4 weeks for 2 months, then every 8 weeks for the remainder of the 2-year trial. The progression of atherosclerosis was measured by ultrasonography at baseline and every 6 months throughout the 2 years of randomized treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116545
|United States, California|
|Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Howard N. Hodis, MD||University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine|