Clinical Trials Directory

Trials / Completed

CompletedNCT00322179

Microarray Analysis of IFN-Induced Gene Expression in Obese and Non-Obese Patients With Chronic Hepatitis C

Status
Completed
Phase
Study type
Observational
Enrollment
22 (actual)
Sponsor
Palo Alto Veterans Institute for Research · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The response rate to interferon-based anti-viral therapy for chronic hepatitis C is lower in patients who are obese. However, it is not clear whether this is related to suboptimal dosing of the medication or alterated response in obese patients. Alterated immune response had been reported in obese patients. The goal of current study is to determine the immune response to interferon in obese compared to non-obese chronic hepatitis C in an tissue culture system.

Detailed description

To examine our hypothesis, we will incubate PBMC samples from obese and nonobese patients with IFN, followed by microarray analysis to compare the IFN response patterns in both groups of patients and to identify genes differentially regulated between these two groups. Identification of such genes will provide important insight to the mechanism of the antiviral effect of HCV. The identified genes will have the potential of serving as targets for pharmaceutical intervention aiming at enhancing the efficacy of IFN therapy for obese patients. This is an open-label study. Ten obese and 10 nonobese patients with chronic hepatitis C will be recruited. For the purpose of this study, obese is defined as body weight \>85 kg and BMI \>30, and nonobese as body weight \<75 kg and BMI\<25.

Conditions

Timeline

Start date
2005-11-01
Primary completion
2007-11-01
Completion
2008-11-01
First posted
2006-05-05
Last updated
2020-03-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00322179. Inclusion in this directory is not an endorsement.