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NCT00707603 Clinical Trial

Chronic Hepatitis C and Insulin Resistance

Hepatitis C Clinical Trial

Official title:
Understanding the Relationship Between Insulin Resistance and Chronic Hepatitis C Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00707603
Other study ID # H04/126
Secondary ID
Status Completed
Phase N/A
First received June 29, 2008
Last updated July 13, 2015
Start date May 2006
Est. completion date December 2008

Study information
Verified date July 2015
Source Garvan Institute of Medical Research
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 55 Years
Eligibility 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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Australia Garvan Institute Of Medical Research Sydney New South Wales
Australia Storr Liver Unit Sydney New South Wales

Sponsors (1)
Lead Sponsor Collaborator
Garvan Institute of Medical Research

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Insulin Resistance by euglycaemic hyperinsulinaemic clamp Liver fat, abdominal fat and muscle fat measures 2 years No
Secondary insulin resistance post treatment of Hep C 2 years No
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