Chronic Hepatitis C and Insulin Resistance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Garvan Institute of Medical Research.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Garvan Institute of Medical Research
ClinicalTrials.gov Identifier:
NCT00707603
First received: June 29, 2008
Last updated: June 30, 2008
Last verified: June 2008
  Purpose

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


Condition
Hepatitis C
Insulin Resistance

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Understanding the Relationship Between Insulin Resistance and Chronic Hepatitis C Infection

Resource links provided by NLM:


Further study details as provided by Garvan Institute of Medical Research:

Primary Outcome Measures:
  • Insulin Resistance by euglycaemic hyperinsulinaemic clamp Liver fat, abdominal fat and muscle fat measures [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • insulin resistance post treatment of Hep C [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum


Estimated Enrollment: 50
Study Start Date: May 2006
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hepatitis C subjects
Due to start therapy for Hepatitis C
Controls
Healthy males

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Hepatitis C patients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707603

Contacts
Contact: Kerry-Lee Milner, MBBS, FRACP +61-410693278

Locations
Australia, New South Wales
Garvan Institute Of Medical Research Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Kerry-Lee Milner, MBBS, FRACP    +61-410693278    k.milner@garvan.org.au   
Contact: Donald Chisholm, MBBS, FRACP    +61-2-92958205    d.chisholm@garvan.org.au   
Principal Investigator: Don Chisholm, MBBS, FRACP         
Storr Liver Unit Recruiting
Sydney, New South Wales, Australia, 2145
Contact: Jacob George, MBBS, FRACP    +61-2- 9845 7705    jacob_george@wmi.usyd.edu.au   
Principal Investigator: Jacob George, MBBS, FRACP         
Sponsors and Collaborators
Garvan Institute of Medical Research
Investigators
Principal Investigator: Donald Chisholm, MBBS, FRACP Garvan Institute of Medical Research
Principal Investigator: Jacob George, MBBS, FRACP Storr Liver Unit
  More Information

No publications provided by Garvan Institute of Medical Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Donald Chisholm, Garvan Institute of Medical Research
ClinicalTrials.gov Identifier: NCT00707603     History of Changes
Other Study ID Numbers: H04/126
Study First Received: June 29, 2008
Last Updated: June 30, 2008
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Garvan Institute of Medical Research:
Insulin resistance
Liver fat
Muscle fat
Abdominal fat
Cytokines

Additional relevant MeSH terms:
Insulin Resistance
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 10, 2014