Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-25 @ 5:03 PM
Study NCT ID:
NCT00707603
Status:
COMPLETED
Last Update Posted:
2015-07-14
First Post:
2008-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chronic Hepatitis C and Insulin Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-13', 'studyFirstSubmitDate': '2008-06-29', 'studyFirstSubmitQcDate': '2008-06-30', 'lastUpdatePostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Resistance by euglycaemic hyperinsulinaemic clamp Liver fat, abdominal fat and muscle fat measures', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'insulin resistance post treatment of Hep C', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Insulin resistance', 'Liver fat', 'Muscle fat', 'Abdominal fat', 'Cytokines'], 'conditions': ['Hepatitis C', 'Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '19962985', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hepatitis C patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasian male\n* Age: 25-55 years\n* Chronic Hepatitis C (PCR positive) and fibrosis ≤ F2 (if liver biopsy done)\n* Genotypes 1 or 3\n* Due to commence antiviral therapy\n* BMI \\< 30\n\nExclusion Criteria:\n\n* Cirrhosis or F3 fibrosis on liver biopsy (if done)\n* \\> 20 g ETOH per day\n* Type 2 Diabetes (need an OGTT if fasting BGL\\> 5.7)\n* Concurrent HIV\n* Other cause of liver disease'}, 'identificationModule': {'nctId': 'NCT00707603', 'briefTitle': 'Chronic Hepatitis C and Insulin Resistance', 'organization': {'class': 'OTHER', 'fullName': 'Garvan Institute of Medical Research'}, 'officialTitle': 'Understanding the Relationship Between Insulin Resistance and Chronic Hepatitis C Infection', 'orgStudyIdInfo': {'id': 'H04/126'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hepatitis C subjects', 'description': 'Due to start therapy for Hepatitis C'}, {'label': 'Controls', 'description': 'Healthy males'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Garvan Institute Of Medical Research', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2145', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Storr Liver Unit', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}], 'overallOfficials': [{'name': 'Donald Chisholm, MBBS, FRACP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Garvan Institute of Medical Research'}, {'name': 'Jacob George, MBBS, FRACP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Storr Liver Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Garvan Institute of Medical Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Head of Endocrinology Department St Vincent's Hospital Sydney", 'investigatorFullName': 'Dr Jerry Greenfield', 'investigatorAffiliation': 'Garvan Institute of Medical Research'}}}}