Status:
COMPLETED
TART - Troglitazone Atherosclerosis Regression Trial
Lead Sponsor:
Parke-Davis
Conditions:
Atherosclerosis
Diabetes Mellitus
Eligibility:
All Genders
30-70 years
Phase:
PHASE2
PHASE3
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.
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 1997
Trial Type :
INTERVENTIONAL
End Date :
April 1 2000
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT00116545
Start Date
January 1 1997
End Date
April 1 2000
Last Update
December 11 2009
Active Locations (1)
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1
Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
Los Angeles, California, United States, 90033