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Gene Regulation by Thiazolidinediones

Phase 4
Completed
Conditions
Inflammatory Bowel Disease
Interventions
Registration Number
NCT00567593
Lead Sponsor
James Lewis
Brief Summary

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

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
RosiglitazoneRosiglitazoneRosiglitazone; 8mg tablet once a day for 14 days
Primary Outcome Measures
NameTimeMethod
PDK4 mRNA14 days
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Pennsylvania Clinical and Translational Research Center

🇺🇸

Philadelphia, Pennsylvania, United States

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