Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2026-03-04 @ 9:36 PM
Study NCT ID:
NCT01858012
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-10
First Post:
2013-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insulin Resistance in HCV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum samples and liver tissue specimens for analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2013-05-16', 'studyFirstSubmitQcDate': '2013-05-17', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'insulin resistance', 'timeFrame': 'baseline, 6 weeks and 18 months', 'description': 'steady state plasma glucose level (mg/dL)'}], 'secondaryOutcomes': [{'measure': 'Insulin secretion', 'timeFrame': 'baseline, 6 weeks and 18 months', 'description': 'insulin secretion rate area under the curve (pmol/min)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['insulin resistance'], 'conditions': ['Insulin Resistance']}, 'referencesModule': {'references': [{'pmid': '29220547', 'type': 'RESULT', 'citation': 'Uribe LA, Bacchetti P, Gelman N, Burchard E, Fitch M, Hellerstein M, Khalili M. Impact of Moderate Alcohol Discontinuation on Insulin Action and Secretion in Latinos With and Without Hepatitis C. Alcohol Clin Exp Res. 2018 Mar;42(3):492-499. doi: 10.1111/acer.13576. Epub 2018 Feb 1.'}, {'pmid': '27007134', 'type': 'RESULT', 'citation': 'Burman BE, Bacchetti P, Khalili M. Moderate Alcohol Use and Insulin Action in Chronic Hepatitis C Infection. Dig Dis Sci. 2016 Aug;61(8):2417-2425. doi: 10.1007/s10620-016-4119-0. Epub 2016 Mar 23.'}, {'pmid': '25156890', 'type': 'RESULT', 'citation': 'Burman BE, Bacchetti P, Ayala CE, Gelman N, Melgar J, Khalili M. Liver inflammation is a risk factor for prediabetes in at-risk latinos with and without hepatitis C infection. Liver Int. 2015 Jan;35(1):101-7. doi: 10.1111/liv.12676. Epub 2014 Sep 20.'}, {'pmid': '34773280', 'type': 'RESULT', 'citation': 'Kim RG, Kramer-Feldman J, Bacchetti P, Grimes B, Burchard E, Eng C, Hu D, Hellerstein M, Khalili M. Disentangling the impact of alcohol use and hepatitis C on insulin action in Latino individuals. Alcohol Clin Exp Res. 2022 Jan;46(1):87-99. doi: 10.1111/acer.14743. Epub 2021 Nov 23.'}, {'pmid': '26554398', 'type': 'RESULT', 'citation': 'Gonzales CA, Bacchetti P, Khalili M. Impact of gender and menopausal status on metabolic parameters in chronic hepatitis C infection. J Viral Hepat. 2016 Mar;23(3):232-9. doi: 10.1111/jvh.12487. Epub 2015 Nov 10.'}, {'pmid': '25196736', 'type': 'RESULT', 'citation': 'Shah SC, Kornak J, Khalili M. Depression is not associated with peripheral insulin resistance in patients with chronic hepatitis C infection. J Viral Hepat. 2015 Mar;22(3):272-80. doi: 10.1111/jvh.12306. Epub 2014 Sep 8.'}, {'pmid': '23086116', 'type': 'RESULT', 'citation': 'Mukhtar NA, Bacchetti P, Ayala CE, Melgar J, Christensen S, Maher JJ, Khalili M. Insulin sensitivity and variability in hepatitis C virus infection using direct measurement. Dig Dis Sci. 2013 Apr;58(4):1141-8. doi: 10.1007/s10620-012-2438-3. Epub 2012 Oct 21.'}, {'pmid': '22399695', 'type': 'RESULT', 'citation': 'Brandman D, Bacchetti P, Ayala CE, Maher JJ, Khalili M. Impact of insulin resistance on HCV treatment response and impact of HCV treatment on insulin sensitivity using direct measurements of insulin action. Diabetes Care. 2012 May;35(5):1090-4. doi: 10.2337/dc11-1837. Epub 2012 Mar 7.'}, {'pmid': '22676360', 'type': 'RESULT', 'citation': 'Mukhtar NA, Ayala C, Maher JJ, Khalili M. Assessment of factors associated with pre-diabetes in HCV infection including direct and dynamic measurements of insulin action. J Viral Hepat. 2012 Jul;19(7):480-7. doi: 10.1111/j.1365-2893.2011.01568.x. Epub 2011 Dec 18.'}, {'pmid': '20578127', 'type': 'RESULT', 'citation': 'Lam KD, Bacchetti P, Abbasi F, Ayala CE, Loeb SM, Shah V, Wen MJ, Reaven GM, Maher JJ, Khalili M. Comparison of surrogate and direct measurement of insulin resistance in chronic hepatitis C virus infection: impact of obesity and ethnicity. Hepatology. 2010 Jul;52(1):38-46. doi: 10.1002/hep.23670.'}]}, 'descriptionModule': {'briefSummary': 'The study hypothesis is that the means by which HCV induces glucose intolerance is through impairment of B-cell function and compensatory hyperinsulinemia in predisposed Latinos with insulin resistance and that HCV eradication improves these abnormalities. It is also hypothesized that moderate alcohol consumption impact insulin sensitivity and secretion with Latinos with or without HCV infection.', 'detailedDescription': 'The study hypothesis is that the means by which HCV induces glucose intolerance is through impairment of B-cell function and compensatory hyperinsulinemia in predisposed Latinos with insulin resistance and that HCV eradication improves these abnormalities. This study addresses changes in the metabolic parameters over time. In addition, it is hypothesized that moderate alcohol consumption impacts insulin resistance and secretion and 30 patients with or without HCV who drink alcohol moderately will have discontinuation of alcohol use for 6 weeks and have metabolic testing before and after alcohol discontinuation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Latinos with and without HCV infection', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria for HCV participants:\n\n* Male or female patients between 18 and 60 years of age\n* Body mass index (BMI) \\> 20 Kg/m2\n* Serologic evidence of hepatitis C infection by anti-HCV antibody\n* Detectable plasma HCV-RNA\n* Compensated liver disease with the following minimum biochemical parameters: prothrombin time \\< 2 seconds prolonged compared to control and bilirubin \\< 3 mg/dL\n* Willingness to provide informed consent\n\nInclusion criteria for healthy Latino volunteers (without HCV infection):\n\n-Same inclusion criteria as above except no evidence of HCV infection (anti-HCV antibody negative)\n\nInclusion criteria for participation in 6-week alcohol abstinence follow-up testing:\n\n-Latinos who are moderate1 alcohol drinkers (1NIAAA definition: female: no more than 3 drinks on any day \\& no more than 7 drinks per week; male: no more than 4 drinks on any day and no more than 14 drinks per week).\n\nSteady-State Plasma Glucose \\< 180 mg/dL\n\nExclusion criteria:\n\n* Hepatitis B or HIV infection\n* Subjects with liver disease other than that caused by HCV\n* Known history of diabetes, or fasting plasma glucose concentration \\>126 mg/dl\n* Known history of cirrhosis of the liver, as well as individuals with decompensated liver disease such as those with ascites, variceal bleeding, and encephalopathy\n* Known history of pancreatitis\n* Prior or current treatment for HCV\n* Heavy alcohol use (\\>80 g/d)\n* Subjects of lipid lowering agents, steroid/ anabolic therapy\n* Significant medical illness that would interfere with the completion of the study\n\nExclusion criteria for healthy (non HCV) Latino volunteers:\n\n-Same as above, including subjects with HCV infection'}, 'identificationModule': {'nctId': 'NCT01858012', 'briefTitle': 'Insulin Resistance in HCV Infection', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Impact of Hepatitis C on Insulin Sensitivity and Insulin Secretion in Latinos', 'orgStudyIdInfo': {'id': 'UCSF 10-00922'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HCV infection', 'description': 'patients with hepatitis C infection', 'interventionNames': ['Behavioral: Moderate alcohol cessation']}, {'label': 'non-HCV infection', 'description': 'healthy controls', 'interventionNames': ['Behavioral: Moderate alcohol cessation']}], 'interventions': [{'name': 'Moderate alcohol cessation', 'type': 'BEHAVIORAL', 'otherNames': ['Hepatitis C therapy'], 'description': 'patients will have moderate alcohol use discontinued for 6 weeks and have before and after alcohol cessation clinical and metabolic assessment and also patients with hepatitis C who have undergo therapy for hepatitis C may have repeat clinical and metabolic assessement', 'armGroupLabels': ['HCV infection', 'non-HCV infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of california San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Mandana Khalili, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}