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Gene Regulation by Thiazolidinediones (GReaT)

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.
 
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

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
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

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Arms and Interventions
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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


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

Eligibility Criteria
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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
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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
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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
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Principal Investigator: James D Lewis, MD, MSCE University of Pennsylvania
More Information
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Responsible Party: James Lewis, Professor of Medicine and Epidemiology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00567593    
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:
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Inflammatory Bowel Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Gastroenteritis
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs