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Chronic Hepatitis C and Insulin Resistance

This study has been completed.
Information provided by (Responsible Party):
Dr Jerry Greenfield, Garvan Institute of Medical Research Identifier:
First received: June 29, 2008
Last updated: July 13, 2015
Last verified: July 2015
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

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

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


Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Hepatitis C patients

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 identifier: NCT00707603

Australia, New South Wales
Garvan Institute Of Medical Research
Sydney, New South Wales, Australia, 2010
Storr Liver Unit
Sydney, New South Wales, Australia, 2145
Sponsors and Collaborators
Garvan Institute of Medical Research
Principal Investigator: Donald Chisholm, MBBS, FRACP Garvan Institute of Medical Research
Principal Investigator: Jacob George, MBBS, FRACP Storr Liver Unit
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Jerry Greenfield, Head of Endocrinology Department St Vincent's Hospital Sydney, Garvan Institute of Medical Research Identifier: NCT00707603     History of Changes
Other Study ID Numbers: H04/126 
Study First Received: June 29, 2008
Last Updated: July 13, 2015
Health Authority: Australia: Human Research Ethics Committee

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

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Insulin Resistance
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on October 21, 2016