Hepatitis C Clinical Trial
Official title:
Understanding the Relationship Between Insulin Resistance and Chronic Hepatitis C Infection
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
| 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 |
Observational Model: Case Control, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| Australia | Garvan Institute Of Medical Research | Sydney | New South Wales |
| Australia | Storr Liver Unit | Sydney | New South Wales |
| Lead Sponsor | Collaborator |
|---|---|
| Garvan Institute of Medical Research |
Australia,
| 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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