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TART - Troglitazone Atherosclerosis Regression Trial

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00116545
First received: June 29, 2005
Last updated: December 9, 2009
Last verified: June 2005
History of Changes
  Purpose

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


Condition Intervention Phase
Atherosclerosis
Diabetes Mellitus
 Drug: troglitazone
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: TART - Troglitazone Atherosclerosis Regression Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

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

Estimated Enrollment: 288
Study Start Date: January 1997
Study Completion Date: April 2000
Primary Completion Date: April 2000 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116545

Locations
United States, California
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00116545     History of Changes
Other Study ID Numbers: AG0028, 991-081-00
Study First Received: June 29, 2005
Last Updated: December 9, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
IDDM
Insulin
cardiovascular disease

Additional relevant MeSH terms:
Atherosclerosis
Diabetes Mellitus
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Troglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013