TART - Troglitazone Atherosclerosis Regression Trial

Completed · Phase 2/Phase 3

Conditions studied: Atherosclerosis, Diabetes Mellitus

In brief

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

Key facts

Study ID

NCT00116545

Run by

Parke-Davis

People needed

288

Starts

1997-01-01

Expected to finish

2000-04-01

Last updated by the study team

2009-12-11

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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