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Gene Regulation by Thiazolidinediones (GReaT)

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ClinicalTrials.gov Identifier: NCT00567593
Recruitment Status : Completed
First Posted : December 5, 2007
Results First Posted : May 8, 2014
Last Update Posted : August 1, 2016
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
James Lewis, University of Pennsylvania

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

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Drug: Rosiglitazone Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Gene Regulation by Thiazolidinediones
Study Start Date : October 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Rosiglitazone
Rosiglitazone; 8mg tablet once a day for 14 days
Drug: Rosiglitazone
8mg tablet once a day for 14 days
Other Name: Avandia




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


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

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

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 Posted: December 5, 2007    Key Record Dates
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