Chronic Hepatitis C and Insulin Resistance

Completed

• Conditions: Hepatitis C; Insulin Resistance

• Registration Number: NCT00707603
• Lead Sponsor: Garvan Institute of Medical Research

Brief Summary

Chronic hepatitis C (CHC) is among the commonest chronic infectious disease in Australia with \>200,000 exposed persons. Amongst non-infectious chronic conditions- Type 2 diabetes, obesity and heart disease are extremely common. This study will examine the relationship between insulin resistance, fat deposition in the liver, muscle and abdomen, and liver injury due to CHC

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2008-06-29
• Study First Submitted QC: 2008-06-30
• Study First Posted: 2008-07-01
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-13
• Last Update Posted: 2015-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• Caucasian male
• Age: 25-55 years
• Chronic Hepatitis C (PCR positive) and fibrosis ≤ F2 (if liver biopsy done)
• Genotypes 1 or 3
• Due to commence antiviral therapy
• BMI < 30

Exclusion Criteria

• Cirrhosis or F3 fibrosis on liver biopsy (if done)
• > 20 g ETOH per day
• Type 2 Diabetes (need an OGTT if fasting BGL> 5.7)
• Concurrent HIV
• Other cause of liver disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insulin Resistance by euglycaemic hyperinsulinaemic clamp Liver fat, abdominal fat and muscle fat measures	2 years

Secondary Outcome Measures

Name	Time	Method
insulin resistance post treatment of Hep C	2 years

Trial Locations

Locations (2)

Garvan Institute Of Medical Research; 🇦🇺 Sydney, New South Wales, Australia

Storr Liver Unit; 🇦🇺 Sydney, New South Wales, Australia