Chronic Hepatitis C and Insulin Resistance
Understanding the Relationship Between Insulin Resistance and Chronic Hepatitis C Infection
1 other identifier
observational
50
1 country
2
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2006
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 29, 2008
CompletedFirst Posted
Study publicly available on registry
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedJuly 14, 2015
July 1, 2015
2.6 years
June 29, 2008
July 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insulin Resistance by euglycaemic hyperinsulinaemic clamp Liver fat, abdominal fat and muscle fat measures
2 years
Secondary Outcomes (1)
insulin resistance post treatment of Hep C
2 years
Study Arms (2)
Hepatitis C subjects
Due to start therapy for Hepatitis C
Controls
Healthy males
Eligibility Criteria
Hepatitis C patients
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Garvan Institute Of Medical Research
Sydney, New South Wales, 2010, Australia
Storr Liver Unit
Sydney, New South Wales, 2145, Australia
Related Publications (1)
Milner KL, van der Poorten D, Trenell M, Jenkins AB, Xu A, Smythe G, Dore GJ, Zekry A, Weltman M, Fragomeli V, George J, Chisholm DJ. Chronic hepatitis C is associated with peripheral rather than hepatic insulin resistance. Gastroenterology. 2010 Mar;138(3):932-41.e1-3. doi: 10.1053/j.gastro.2009.11.050. Epub 2009 Dec 4.
PMID: 19962985DERIVED
Biospecimen
serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Donald Chisholm, MBBS, FRACP
Garvan Institute of Medical Research
- PRINCIPAL INVESTIGATOR
Jacob George, MBBS, FRACP
Storr Liver Unit
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Endocrinology Department St Vincent's Hospital Sydney
Study Record Dates
First Submitted
June 29, 2008
First Posted
July 1, 2008
Study Start
May 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
July 14, 2015
Record last verified: 2015-07