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

First Received on June 29, 2008. Last Updated on June 30, 2008 History of Changes

Sponsor:	Garvan Institute of Medical Research
Information provided by:	Garvan Institute of Medical Research
ClinicalTrials.gov Identifier:	NCT00707603

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:

MedlinePlus related topics: Diabetes Medicines Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Insulin Insulin beef Hepatitis A Vaccines

U.S. FDA Resources

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

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):

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. Epub 2009 Dec 4.

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:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012