Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00707603