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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322179
• Other study ID #: CHR0036ARG
• Secondary ID: PEG215
• Status: Completed
• Start date: November 2005
• Est. completion date: November 2008

Study information

• Verified date: March 2020
• Source: Palo Alto Veterans Institute for Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• obese (weight > 85kg and BMI>30) or non-obese patients (<75kg and BMI <25) with chronic Hepatitis C

• Chronic Hepatitis C infection with documented HCV RNA

• Body habitat either as obese or non-obese as defined above

• Currently not under IFN therapy

• Non-African American

Exclusion Criteria:

• Body habitat neither obese or non-obese as defined for the purpose of this study

• Unable to give consent

• On immunomodulatory agents such as prednisone

• Active infection other than Hepatitis C

• Co-infection with HBV or HIV

• Active or excessive alcohol use

• Other cause of chronic Hepatitis

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Obesity

Locations

Country	Name	City	State
United States	VA Palo Alto Health Care System	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Palo Alto Veterans Institute for Research	Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

References & Publications (5)

Bressler BL, Guindi M, Tomlinson G, Heathcote J. High body mass index is an independent risk factor for nonresponse to antiviral treatment in chronic hepatitis C. Hepatology. 2003 Sep;38(3):639-44. — View Citation

Camps J, Crisóstomo S, García-Granero M, Riezu-Boj JI, Civeira MP, Prieto J. Prediction of the response of chronic hepatitis C to interferon alfa: a statistical analysis of pretreatment variables. Gut. 1993 Dec;34(12):1714-7. — View Citation

Farooqi IS, Matarese G, Lord GM, Keogh JM, Lawrence E, Agwu C, Sanna V, Jebb SA, Perna F, Fontana S, Lechler RI, DePaoli AM, O'Rahilly S. Beneficial effects of leptin on obesity, T cell hyporesponsiveness, and neuroendocrine/metabolic dysfunction of human congenital leptin deficiency. J Clin Invest. 2002 Oct;110(8):1093-103. — View Citation

Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Gonçales FL Jr, Häussinger D, Diago M, Carosi G, Dhumeaux D, Craxi A, Lin A, Hoffman J, Yu J. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002 Sep 26;347(13):975-82. — View Citation

Ji X, Cheung R, Cooper S, Li Q, Greenberg HB, He XS. Interferon alfa regulated gene expression in patients initiating interferon treatment for chronic hepatitis C. Hepatology. 2003 Mar;37(3):610-21. Erratum in: Hepatology. 2003 Jun;37(6):1503. — View Citation