Gene Regulation by Thiazolidinediones (GReaT)

James Lewis

Status and phase

Completed

Phase 4

Conditions

Inflammatory Bowel Disease

Treatments

Drug: Rosiglitazone

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00567593

DK59961

R01DK059961 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to determine the effect of rosiglitazone on the genes of the colon

Full description

The primary aim of the study is to examine the effect of rosiglitazone (Avandia) on gene regulation in colonic epithelium in the absence of pathologic acute and chronic intestinal inflammation. The secondary aims are to determine the effect of rosiglitazone (Avandia) therapy on T cell activation and cytokine expression in the absence of pathologic acute and chronic intestinal inflammation.

Enrollment

12 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Capable of giving informed consent
Agrees to use a barrier method of birth control for the duration of the study

Exclusion criteria

History of inflammatory bowel disease
Has taken prescription or over the counter medications in the two weeks prior to enrollment
History of diabetes, heart failure, angina, hypertension, coronary heart disease, cancer, bleeding disorder, HIV, AIDS
Fasting LDL >160 mg/dl
History of smoking in the year prior to enrollment
Pregnant or breastfeeding