Gene Regulation by Thiazolidinediones - Full Text View

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00567593

Purpose

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

Condition	Intervention	Phase
Inflammatory Bowel Disease	Drug: Rosiglitazone	Phase IV

Genetics Home Reference related topics: Crohn disease

Drug Information available for: Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Gene Regulation by Thiazolidinediones

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

There are no pre-specified endpoints for this study. Rather, we will use an unbiased approach to discovering changes in gene regulation using mass screening with gene microarray techniques. [ Time Frame: 14 ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	October 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single	Drug: Rosiglitazone 8mg tablet once a day for 14 days

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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567593

Locations

United States, Pennsylvania
University of Pennsylvania Clinical and Translational Research Center
Philadelphia, Pennsylvania, United States, 19104

Sponsors and Collaborators

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

Investigators

Principal Investigator:

James D Lewis, MD, MSCE

University of Pennsylvania

More Information

Responsible Party:	University of Pennsylvania ( James D. Lewis, MD, MSCE )
Study ID Numbers:	DK56691 - GREAT
Study First Received:	December 3, 2007
Last Updated:	March 31, 2008
ClinicalTrials.gov Identifier:	NCT00567593
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
2,4-thiazolidinedione
Inflammatory Bowel Diseases

Gastroenteritis
Intestinal Diseases
Rosiglitazone

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009