Gene Regulation by Thiazolidinediones | Clinical Trial

Key information

Conditions

Inflammatory Bowel Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Pennsylvania Clinical and Translational Research Center

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rosiglitazone

Drug

8mg tablet once a day for 14 days

Other names: Avandia

Primary outcomes

PDK4 mRNA

Time frame: 14 days

Sponsors and collaborators

Lead sponsor

James Lewis

Other

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: GReaT

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Dec 5, 2007
Registry last updated: Aug 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed