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Gene Regulation by Thiazolidinediones (GReaT)

Primary Purpose

Inflammatory Bowel Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rosiglitazone
Sponsored by
James Lewis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammatory Bowel Disease

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Pennsylvania Clinical and Translational Research Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Rosiglitazone

Arm Description

Rosiglitazone; 8mg tablet once a day for 14 days

Outcomes

Primary Outcome Measures

PDK4 mRNA

Secondary Outcome Measures

Full Information

First Posted
December 3, 2007
Last Updated
July 3, 2016
Sponsor
James Lewis
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00567593
Brief Title
Gene Regulation by Thiazolidinediones
Acronym
GReaT
Official Title
Gene Regulation by Thiazolidinediones
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
James Lewis
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rosiglitazone
Arm Type
Other
Arm Description
Rosiglitazone; 8mg tablet once a day for 14 days
Intervention Type
Drug
Intervention Name(s)
Rosiglitazone
Other Intervention Name(s)
Avandia
Intervention Description
8mg tablet once a day for 14 days
Primary Outcome Measure Information:
Title
PDK4 mRNA
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James D Lewis, MD, MSCE
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Clinical and Translational Research Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Gene Regulation by Thiazolidinediones

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