Chronic Hepatitis C and Insulin Resistance | NCT00707603

Studies
Chronic Hepatitis C and Insulin Resistance

NCT00707603

Sponsor

Garvan Institute of Medical Research

Status

Completed

Last Update Posted

Jul 14, 2015Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Hepatitis C
Insulin Resistance

Interventions

Not provided

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jun 29, 2008

First Submission Date that Met QC Criteria

Jun 30, 2008

First Posted Date

Jul 1, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2015

Last Update Posted Date

Jul 14, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Jerry Greenfield, Head of Endocrinology Department St Vincent's Hospital Sydney, Garvan Institute of Medical ResearchPrincipal Investigator

Lead Sponsor

Garvan Institute of Medical ResearchOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hepatitis C subjects		Due to start therapy for Hepatitis C
Controls		Healthy males

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Insulin Resistance by euglycaemic hyperinsulinaemic clamp Liver fat, abdominal fat and muscle fat measures		2 years

Secondary Outcomes

Measure	Description	Time Frame
insulin resistance post treatment of Hep C		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Hepatitis C patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Donald Chisholm, MBBS, FRACP	Garvan Institute of Medical Research	Principal Investigator
Jacob George, MBBS, FRACP	Storr Liver Unit	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Garvan Institute Of Medical Research		Sydney	New South Wales	2010	Australia
Storr Liver Unit

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19962985	Derived	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.

ID	Term
D006526	Hepatitis C
D007333	Insulin Resistance
D005234	Fatty Liver

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human