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TART - Troglitazone Atherosclerosis Regression Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00116545
Recruitment Status : Completed
First Posted : June 30, 2005
Last Update Posted : December 11, 2009
Information provided by:
National Institute on Aging (NIA)

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: TART - Troglitazone Atherosclerosis Regression Trial
Study Start Date : January 1997
Actual Primary Completion Date : April 2000
Actual Study Completion Date : April 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Primary Outcome Measures :
  1. rate of change of the right distal common carotid artery far wall intima-media thickness (IMT) measured every 6 months
  2. flow mediated brachial artery vasoactivity

Secondary Outcome Measures :
  1. carbohydrate and lipid metabolism

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00116545

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United States, California
Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
Los Angeles, California, United States, 90033
Sponsors and Collaborators
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Principal Investigator: Howard N. Hodis, MD University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
Layout table for additonal information Identifier: NCT00116545    
Other Study ID Numbers: AG0028
First Posted: June 30, 2005    Key Record Dates
Last Update Posted: December 11, 2009
Last Verified: June 2005
Keywords provided by National Institute on Aging (NIA):
cardiovascular disease
Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Hypoglycemic Agents
Physiological Effects of Drugs