Gene Regulation by Thiazolidinediones

Inflammatory Bowel Disease Clinical Trial

— GReaT  

Official title:

Gene Regulation by Thiazolidinediones

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00567593
• Other study ID #: DK59961
• Secondary ID: R01DK059961
• Status: Completed
• Phase: Phase 4
• First received: December 3, 2007
• Last updated: April 9, 2014
• Start date: October 2007
• Est. completion date: March 2008

Study information

• Verified date: April 2014
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases

Intervention

Drug:
• Rosiglitazone
8mg tablet once a day for 14 days

Locations

Country	Name	City	State
United States	University of Pennsylvania Clinical and Translational Research Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
James Lewis	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PDK4 mRNA		14	No