Gene Regulation by Thiazolidinediones

NCT ID: NCT00567593

Last Updated: 2016-08-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Inflammatory Bowel Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Rosiglitazone

Rosiglitazone; 8mg tablet once a day for 14 days

Group Type OTHER

Rosiglitazone

Intervention Type DRUG

8mg tablet once a day for 14 days

Interventions

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Rosiglitazone

8mg tablet once a day for 14 days

Intervention Type DRUG

Other Intervention Names

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Avandia

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

James Lewis

OTHER

Sponsor Role lead

Responsible Party

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James Lewis

Professor of Medicine and Epidemiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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James D Lewis, MD, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania Clinical and Translational Research Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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R01DK059961

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DK59961

Identifier Type: -

Identifier Source: org_study_id

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