Exploring the effect of disturbance in insulin metabolism on the treatment response of hepatitis C virus to find options to improve response rate

Completed

• Conditions: Hepatitis C Virus (HCV) infection; Infections and Infestations; Chronic viral hepatitis

• Registration Number: ISRCTN64847145
• Lead Sponsor: Imperial College London and Imperial College Healthcare NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-15
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Chronic HCV genotype 1 infection
2. Chronic HCV and compensated liver cirrhosis who failed to respond to previous treatment
3. Age >17, <70
4. Eligible for interferon therapy

Exclusion Criteria

1. HIV or HBV co-infection
2. Current use antidiabetic medication (e.g., insulin, metformin or thiazolidinedione)
3. Significant respiratory, cardiac or renal dysfunction
4. Body Mass Index > 30 kg/m2

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insulin resistance:<br>Total body insulin resistance and hepatic insulin resistance will be measured using the hyperinsulinaemic euglycaemic clamp.

Secondary Outcome Measures

Name	Time	Method
1. Interferon sensitivity (Interferon-Inducible Protein [IP10] in blood measured by ELISA and in peripheral blood mononuclear cells [PBMC] by mRNA)<br>2. Viral dynamic response measured by serial HCV PCR levels <br>3. Treatment response measured by serial HCV PCR levels