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Chronic Hepatitis C and Insulin Resistance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00707603
First Posted: July 1, 2008
Last Update Posted: July 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr Jerry Greenfield, Garvan Institute of Medical Research
  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 Dr Jerry Greenfield, 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 ]

Secondary Outcome Measures:
  • insulin resistance post treatment of Hep C [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA
serum

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)
Groups/Cohorts
Hepatitis C subjects
Due to start therapy for Hepatitis C
Controls
Healthy males

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00707603


Locations
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
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Jerry Greenfield, Head of Endocrinology Department St Vincent's Hospital Sydney, Garvan Institute of Medical Research
ClinicalTrials.gov Identifier: NCT00707603     History of Changes
Other Study ID Numbers: H04/126
First Submitted: June 29, 2008
First Posted: July 1, 2008
Last Update Posted: July 14, 2015
Last Verified: July 2015

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

Additional relevant MeSH terms:
Hepatitis
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
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs