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Gene Regulation by Thiazolidinediones (GReaT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00567593
First Posted: December 5, 2007
Last Update Posted: August 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
James Lewis, University of Pennsylvania
  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 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Gene Regulation by Thiazolidinediones

Resource links provided by NLM:


Further study details as provided by James Lewis, University of Pennsylvania:

Primary Outcome Measures:
  • PDK4 mRNA [ Time Frame: 14 days ]

Enrollment: 12
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
Rosiglitazone
Rosiglitazone; 8mg tablet once a day for 14 days
Drug: Rosiglitazone
8mg tablet once a day for 14 days
Other Name: Avandia

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00567593


Locations
United States, Pennsylvania
University of Pennsylvania Clinical and Translational Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
James Lewis
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: James Lewis, Professor of Medicine and Epidemiology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00567593     History of Changes
Other Study ID Numbers: DK59961
R01DK059961 ( U.S. NIH Grant/Contract )
First Submitted: December 3, 2007
First Posted: December 5, 2007
Results First Submitted: December 20, 2013
Results First Posted: May 8, 2014
Last Update Posted: August 1, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Rosiglitazone
2,4-thiazolidinedione
Hypoglycemic Agents
Physiological Effects of Drugs