Expired Study
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Philadelphia, Pennsylvania 19104


Purpose:

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


Study summary:

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.


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


Study is Available At:


Original ID:

DK59961


NCT ID:

NCT00567593


Secondary ID:

R01DK059961


Study Acronym:

GReaT


Brief Title:

Gene Regulation by Thiazolidinediones


Official Title:

Gene Regulation by Thiazolidinediones


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

40 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Pennsylvania


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Intervention Model:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

10


Enrollment Type:

Actual


Overall Contact Information

Official Name:James D Lewis, MD, MSCE
Principal Investigator
University of Pennsylvania

Study Dates

Start Date:October 2007
Completion Date:March 2008
Completion Type:Actual
Primary Completion Date:March 2008
Primary Completion Type:Actual
Verification Date:June 2013
Last Changed Date:June 22, 2013
First Received Date:December 3, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:There are no pre-specified endpoints for this study. Rather, we will use an unbiased approach to discovering changes in gene regulation using mass screening with gene microarray techniques.
Time Frame:14
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Rosiglitazone
Description:8mg tablet once a day for 14 days
Arm Name:Single
Other Name:Avandia

Study Arms

Study Arm Type:Other
Arm Name:Single

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:James Lewis
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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