Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-29 @ 12:23 AM
Study NCT ID:
NCT07191561
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatic Lipid Metabolism-Alcohol Use Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09-22', 'completionDateStruct': {'date': '2029-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-09-24', 'studyFirstSubmitQcDate': '2025-09-24', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transcriptome changes in lipid metabolism between week 1 and week 4 of alcohol cessation.', 'timeFrame': 'November 2029', 'description': 'Analysis of liver biopsies'}], 'secondaryOutcomes': [{'measure': 'Other transcriptome changes between week 1 and week 4 of alcohol cessation', 'timeFrame': 'November 2029'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alcohol', 'Liver', 'Biopsy'], 'conditions': ['Alcohol Use Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_001764-DK.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Patients with hepatic steatosis due to alcohol will be offered liver biopsies when they enter a detoxification program. The first biopsy will occur in the first week of admission and the second in the fourth week when the steatosis has resolved. The hepatic transcriptome will be compared,', 'detailedDescription': 'Study Description:\n\nThe liver is central to lipid metabolism, intimately involved with lipid uptake, lipoprotein synthesis and lipid synthesis. Alcohol has known effects on changing lipid composition including increases in HDL and decreases in LDL; nevertheless, the underlying mechanisms of this altered lipoprotein metabolism is not understood. Current spectroscopy data characterize the changes in lipoprotein profiles with alcohol cessation. We aim to study liver lipid metabolism by performing liver biopsies and transcriptome analysis in participants with alcohol use disorder.\n\nObjectives:\n\nPrimary Objective:\n\nTo understand the transcriptomics of hepatic lipid metabolism in alcohol use disorder\n\nSecondary Objective:\n\nTo understand other transcriptome changes in alcohol use cessation.\n\nTertiary Objective:\n\nTo elucidate the genomics-transcriptomics-metabolomics pathway of hepatic lipid metabolism in alcohol use disorder.\n\nEndpoints:\n\nPrimary Endpoints:\n\n-Transcriptome changes in lipid metabolism between week 1 and week 4.\n\nSecondary Endpoints:\n\n-Other transcriptome changes between week 1 and week 4.\n\nTertiary Endpoints:\n\n* To make connections with existing genetics and metabolomics data with transcriptomics.\n* Stool microbiome studies'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants diagnosed with alcohol use disorder, currently under inpatient treatment at the NIH.', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Any individual \\>=18 years of age who is enrolled in 14-AA-0181 and is seeking inpatient treatment.\n* Vibration Controlled Elastography parameters with initial CAP of \\>295dB/m.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnancy\n* Existing diagnosis of hyperlipidemia or essential hypertension\n* Hemoglobin A1c \\>= 6.5%\n* Waist to hip ratio: \\>=0.90 in males, \\>=0.85 in females\n* Existing use of cholesterol lowering medications including statins, fibrates, or other similar medications used for the purposes of treating hyperlipidemia.\n* Those with evidence of severe alcoholic hepatitis with a Maddrey s Discriminant Function \\> 32\n* Those with other chronic liver diseases including chronic hepatitis B (positive hepatitis B surface Ag on admission), hepatitis C (positive hepatitis C RNA), or autoimmune hepatitis (clinical diagnosis based on high titer of positive ANA and or anti smooth muscle Ab and a history of autoimmune disease)\n* HIV infection\n* Contraindication or inability to perform a liver biopsy.\n\n * Participants with coagulopathy (PT/PTT values that are prolonged (Bullet) 3 seconds from the upper limit of the normal, including treatment with oral and parenteral anticoagulants), thrombocytopenia (\\< 70,000), abnormal bleeding time or platelet dysfunction. Antiplatelet agents taken for cardiovascular prevention will not exclude participants, unless they cannot be stopped safely for the performance of a liver biopsy.\n * Hemoglobin level \\< 11 g/dL\n * Inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT07191561', 'briefTitle': 'Hepatic Lipid Metabolism-Alcohol Use Disorder', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Mechanisms in Hepatic Lipid Metabolism in Alcohol Use Disorder: From Genomics, Transcriptomics to Metabolomics', 'orgStudyIdInfo': {'id': '10001764'}, 'secondaryIdInfos': [{'id': '001764-DK'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Liver biopsy', 'description': 'All participants in the study will undergo liver biopsies', 'interventionNames': ['Diagnostic Test: Liver biopsy']}], 'interventions': [{'name': 'Liver biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Biopsy of the liver', 'armGroupLabels': ['Liver biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'contacts': [{'name': 'NIH Clinical Center Office of Patient Recruitment (OPR)', 'role': 'CONTACT', 'email': 'ccopr@nih.gov', 'phone': '800-411-1222', 'phoneExt': 'TTY dial 711'}], 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'centralContacts': [{'name': 'Sawsan Fathma, M.D.', 'role': 'CONTACT', 'email': 'sawsan.fathma@nih.gov', 'phone': '(301) 451-1273'}, {'name': 'Theo Heller, M.D.', 'role': 'CONTACT', 'email': 'theoh@intra.niddk.nih.gov', 'phone': '(301) 402-7147'}], 'overallOfficials': [{'name': 'Theo Heller, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}