Recruiting

RosiglitazoneRosiglitazone Therapy In The Prevention Of Coronary Artery Disease In Patients With Impaired Glucose Tolerance

Sponsor:

Denver Research Institute

Code:

NCT00733174

Conditions

Impaired Glucose Tolerance

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Interventions

Rosiglitazone

Placebo

Study Details

Brief summary:

Subjects with impaired glucose tolerance will be randomized to either rosiglitazone or placebo for a 18 month period. The study will look at baseline, 12 month and 18 month data for exercise tolerance, coronary artery calcification and diabetes indicators.

Conditions

Impaired Glucose Tolerance

Study ID

NCT00733174

Start date

Mar, 2004

Status verified date

Aug, 2008

Primary completion date

Jan, 2009

Anticipated

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Subjects must sign the informed consent to participate in the study.
Male or female adults ages 25-75 years.
Female subjects must be postmenopausal (i.e., > 6 months without menstrual period), surgically sterile, or using effective barrier contraceptive measures (Intra-Uterine Device (IUD), diaphragm with spermicide or condom with spermicide).
Women of childbearing potential must use effective barrier contraceptive measures for at least 1 month prior to visit 1, and should continue to use the same contraceptive method during the study and for 30 days after discontinuing study medication.
Female subjects of childbearing potential must have a negative urine pregnancy test.
Subjects must have an FPG < 126 mg/dL at Screening 1 AND Screening 2, a C-peptide > 2.0 ng/mL and a HbA1c <6.5%.
Subjects must have a Body Mass Index 25-40 (must be < 300 lbs).
Subjects must have a 2 hour post-prandial glucose 140-199 mg/dL at Screening 1 AND Screening 2. If the 2 hour post-prandial glucose result is 130-139 mg/dL at Screening 2, subjects will be allowed to repeat the OGTT.

Exclusion Criteria:

Women who are lactating, pregnant, or planning to become pregnant during the study will be excluded.
Women using hormone contraception or on hormone replacement therapy will be excluded.
Subjects with any clinically significant abnormality identified on the Screening physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study will also be excluded.
Use of any other investigational agents or participation in any other investigational studies during the study period will not be allowed.
Patients will also be excluded if there is a presence of clinically significant hepatic disease or patient with LFT levels > 2 times the upper limit of normal laboratory range
Subjects with a documented history of significant hypersensitivity (e.g., difficulty swallowing, difficulty breathing, tachycardia or skin reaction) to thiazolidinediones
Subjects with any contraindications to rosiglitazone
Presence of unstable or severe (New York Heart Association-NYHA class 3 or 4) angina, including angina requiring continual nitrate treatment for symptomatic relief, or coronary insufficiency
Subjects with HYHA class 3 or 4 of congestive heart failure requiring drug therapy; systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg
History of cancer (except non-melanomatous skin carcinoma)
Active alcohol or drug abuse within the last 6 months
Subjects with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids
Subjects who are unable to understand dosing directions or swallow study medications
Subjects who are currently smoking
Subjects unable to adhere to protocol requirements.
Persons with angina or any other cardiac or pulmonary symptoms that would potentially limit exercise performance will be excluded.
Persons taking prescription or over-the-counter weight loss medications or persons on a weight loss program with ongoing weight loss, or starting an intensive exercise program within 30 days of screening will also be excluded.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

Rosiglitazone

placebo comparator: 2

Placebo

Interventions

Rosiglitazone

tablet

Placebo

Primary outcome measure

Effect of rosiglitazone vs. placebo on exercise tolerance [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Stacey Mitchell, BSN, RN

303-399-8020 stacey.mitchell@va.gov

Locations

South Federal Family Practice

Recruiting

Denver, Colorado, United States, 80219

Contacts

Annette Grissett, MA

303-934-2202 annetteg@roydurbin.com

Stacey Mitchell, BSN, RN

303-399-8020 stacey.mitchell@va.gov

More Information

Sponsor

Denver Research Institute

Last update posted

Aug 12, 2008

Last verified

Aug, 2008

Keywords

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Denver Research Institute on 2008-08-12.