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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00707603




Registration number
NCT00707603
Ethics application status
Date submitted
29/06/2008
Date registered
1/07/2008
Date last updated
14/07/2015

Titles & IDs
Public title
Chronic Hepatitis C and Insulin Resistance
Scientific title
Understanding the Relationship Between Insulin Resistance and Chronic Hepatitis C Infection
Secondary ID [1] 0 0
H04/126
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Insulin Resistance 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Hepatitis C subjects - Due to start therapy for Hepatitis C

Controls - Healthy males
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Insulin Resistance by euglycaemic hyperinsulinaemic clamp Liver fat, abdominal fat and muscle fat measures
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
insulin resistance post treatment of Hep C
Timepoint [1] 0 0
2 years

Eligibility
Key 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
Minimum age
25 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2008
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Garvan Institute Of Medical Research - Sydney
Recruitment hospital [2] 0 0
Storr Liver Unit - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
2145 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Garvan Institute of Medical Research
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00707603
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Donald Chisholm, MBBS, FRACP
Address 0 0
Garvan Institute of Medical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00707603