Gene Regulation by Thiazolidinediones (GReaT)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
James Lewis, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00567593
First received: December 3, 2007
Last updated: April 9, 2014
Last verified: April 2014
  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: Open Label
Primary Purpose: Basic Science
Official Title: Gene Regulation by Thiazolidinediones

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • PDK4 mRNA [ Time Frame: 14 ] [ Designated as safety issue: No ]

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
Single
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
James Lewis
Investigators
Principal Investigator: James D Lewis, MD, MSCE University of Pennsylvania
  More Information

No publications provided

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
Study First Received: December 3, 2007
Results First Received: December 20, 2013
Last Updated: April 9, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 26, 2014