TART - Troglitazone Atherosclerosis Regression Trial

Sponsor

Parke-Davis (Industry)

Overall Status

Completed

CT.gov ID

NCT00116545

Collaborator

(none)

288

Enrollment

Location

Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if troglitazone reduces the progression of early preintrusive carotid atherosclerosis in insulin-requiring diabetes patients.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis Diabetes Mellitus	Drug: troglitazone	Phase 2/Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

TART - Troglitazone Atherosclerosis Regression Trial

Study Start Date :

Jan 1, 1997

Actual Primary Completion Date :

Apr 1, 2000

Actual Study Completion Date :

Apr 1, 2000

Outcome Measures

Primary Outcome Measures

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 []

Secondary Outcome Measures

carbohydrate and lipid metabolism []

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Men and women ages 30-70 years
Diabetes: fasting glucose over 140 mg/dL but under 350 mg/dL on at least 2 occasions
At least 30 years of age at onset of diabetes
Metabolic control and management requiring insulin without other anti-diabetic medications
Willingness to sign informed consent

Exclusion Criteria:

Known sensitivity to troglitazone or other thiazolidinediones
For premenopausal females: pregnancy, breastfeeding, unwilling to use effective contraception for the duration of the trial
Active liver disease or hepatic dysfunction; renal dysfunction; high blood pressure; major vascular events within 6 months prior to randomization; untreated hypothyroidism or uncured hyperthyroidism; other severe or unstable disease within 5 years of randomization
Medical illness that may require oral or parenteral glucocorticoid therapy
Physical disability that would interfere with diabetes self-management
Untreated or unstable diabetic retinopathy
History of insulin allergy
Present or recent history of alcohol intake over 5 drinks per day or substance abuse
Participation in another clinical trial
Currently taking nicotinic acid

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine	Los Angeles	California	United States	90033

Sponsors and Collaborators

Parke-Davis

Investigators

Principal Investigator: Howard N. Hodis, MD, University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine