Chronic Hepatitis C and Insulin Resistance

NCT ID: NCT00707603

Last Updated: 2015-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Hepatitis C Insulin Resistance

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Hepatitis C subjects

Due to start therapy for Hepatitis C

No interventions assigned to this group

Controls

Healthy males

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Garvan Institute of Medical Research

OTHER

Sponsor Role lead

Responsible Party

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Dr Jerry Greenfield

Head of Endocrinology Department St Vincent's Hospital Sydney

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Donald Chisholm, MBBS, FRACP

Role: PRINCIPAL_INVESTIGATOR

Garvan Institute of Medical Research

Jacob George, MBBS, FRACP

Role: PRINCIPAL_INVESTIGATOR

Storr Liver Unit

Locations

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Garvan Institute Of Medical Research

Sydney, New South Wales, Australia

Site Status

Storr Liver Unit

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 19962985 (View on PubMed)

Other Identifiers

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H04/126

Identifier Type: -

Identifier Source: org_study_id

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