Phase 4 N=12 Basic Science

Gene Regulation by Thiazolidinediones

Inflammatory Bowel Disease

Bottom Line

View on ClinicalTrials.gov: NCT00567593 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2014

Primary outcome: Primary: PDK4 mRNA — .776; 1.30 copies/nL — p=.01

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Rosiglitazone (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: James Lewis
Primary completion: Mar 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY PDK4 mRNA	.776; 1.30	.01 sig

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00567593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.