Hepatitis CNCT00707603
Chronic Hepatitis C and Insulin Resistance
An observational study of Hepatitis C and Insulin Resistance, run by Garvan Institute of Medical Research at 2 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 25 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Insulin Resistance
- How many people
- 50 participants
- Where
- 2 sitesAustralia
- Study dates
- May 2006to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Hepatitis C patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Garvan Institute Of Medical Research
Sydney, New South Wales, 2010
Storr Liver Unit
Sydney, New South Wales, 2145
About this study
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
- Conditions
- Hepatitis C, Insulin Resistance
- Keywords
- Insulin resistance, Liver fat, Muscle fat, Abdominal fat, Cytokines
- Medical subject headings
- Hepatitis C, Insulin Resistance, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis C subjects | Due to start therapy for Hepatitis C | |
| Controls | Healthy males |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Resistance by euglycaemic hyperinsulinaemic clamp Liver fat, abdominal fat and muscle fat measures
Measured: 2 years
Secondary outcomes (1)
insulin resistance post treatment of Hep C
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2008 (estimated)
- Study startMay 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Garvan Institute of Medical Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jerry Greenfield, Garvan Institute of Medical Research
- Investigators
- Donald Chisholm, MBBS, FRACP, Principal investigator, Garvan Institute of Medical ResearchJacob George, MBBS, FRACP, Principal investigator, Storr Liver Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707603
- Sponsor's protocol ID
- H04/126
- Status last verified
- Jul 2015
- First submitted
- 29 Jun 2008
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19962985
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Relationship Between Insulin Resistance and Chronic Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT00707603
- Acronym / sponsor ID
- H04/126
- Conditions
- Hepatitis C, Insulin Resistance
- Keywords
- Insulin resistance, Liver fat, Muscle fat, Abdominal fat, Cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Garvan Institute of Medical ResearchUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 1 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatitis C subjects | – | –Due to start therapy for Hepatitis C |
| Controls | – | –Healthy males |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Hepatitis C patients
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Insulin Resistance by euglycaemic hyperinsulinaemic clamp Liver fat, abdominal fat and muscle fat measures
Time frame: 2 years
1 secondary outcome
insulin resistance post treatment of Hep C
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
- Derived from this study: PubMed 19962985Milner 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.
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Chisholm, MBBS, FRACP principal investigator
Garvan Institute of Medical Research
Jacob George, MBBS, FRACP principal investigator
Storr Liver Unit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C and Insulin Resistance, run by Garvan Institute of Medical Research at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Resistance by euglycaemic hyperinsulinaemic clamp Liver fat, abdominal fat and muscle fat measures (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00707603, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2015.