Diabetes Mellitus Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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