[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642297":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":24,"responsibleParty":62,"collaborators":10,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":10,"enrollmentInfo":74,"targetDuration":10,"studyType":77,"phases":10,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":89,"whyStopped":10,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Arm A - Autoimmune Hepatitis (AIH)",null,"12 adult outpatients with a confirmed diagnosis of autoimmune hepatitis (AIH), attending the Hepatology Outpatient Unit (UOSD Epatopatie) of IRCCS \"S. de Bellis\".",{"label":13,"type":10,"description":14,"interventionNames":10},"Arm B - Non-Alcoholic Fatty Liver Disease (NAFLD)","12 adult outpatients with a confirmed diagnosis of non-alcoholic fatty liver disease (NAFLD), attending the Hepatology Outpatient Unit (UOSD Epatopatie) of IRCCS \"S. de Bellis\".",[16,21],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Maria Notarnicola, biologyst","CONTACT","+39 0804994623","maria.notarnicola@irccsdebellis.it",{"name":22,"role":18,"phone":19,"phoneExt":10,"email":23},"Valentina De Nunzio","valentina.denunzio@irccsdebellis.it",[25],{"facility":26,"status":10,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"IRCCS \"S. de Bellis\" - Nutritional Biochemistry Lab","Castellana Grotte","Bari","70013","Italy","IT",{"type":33,"coordinates":34},"Point",[35,36],17.16549,40.88643,{"lat":36,"lon":35},[39,42,43,46,49,50,52,54,56,58,60],{"name":40,"role":18,"phone":41,"phoneExt":10,"email":20},"Maria Notarnicola, Biologyst","0804994623",{"name":22,"role":18,"phone":41,"phoneExt":10,"email":23},{"name":44,"role":45,"phone":10,"phoneExt":10,"email":10},"Maria Notarnicola","PRINCIPAL_INVESTIGATOR",{"name":47,"role":48,"phone":10,"phoneExt":10,"email":10},"Emanuela Aloisio Caruso","SUB_INVESTIGATOR",{"name":22,"role":48,"phone":10,"phoneExt":10,"email":10},{"name":51,"role":48,"phone":10,"phoneExt":10,"email":10},"Giuliano Pinto",{"name":53,"role":48,"phone":10,"phoneExt":10,"email":10},"Angela Tafaro",{"name":55,"role":48,"phone":10,"phoneExt":10,"email":10},"Maria Principia Scavo",{"name":57,"role":48,"phone":10,"phoneExt":10,"email":10},"Raffaele Cozzolongo",{"name":59,"role":48,"phone":10,"phoneExt":10,"email":10},"Endrit Shahini",{"name":61,"role":48,"phone":10,"phoneExt":10,"email":10},"Pasqua Letizia Pesole",{"type":63,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100642297","molecular-characterization-of-autoimmune-hepatitis-a-lipidomic-approach-100642297",false,"NCT07644936","Molecular Characterization of Autoimmune Hepatitis: A Lipidomic Approach","Molecular Characterization of Autoimmune Hepatitis Through Lipidomic Analysis and Extracellular Vesicle Profiling: A Controlled Pilot Clinical Study","AIH-LIPID","Inclusion Criteria:\n\nARM A:\n\n* Confirmed diagnosis of autoimmune hepatitis (AIH);\n* Adult age (≥18 years);\n* Ability to provide written informed consent; Attending the Hepatology Outpatient Unit of IRCCS \"S. de Bellis\"\n\nARM B:\n\nExclusion Criteria:\n\n* Confirmed diagnosis of non-alcoholic fatty liver disease (NAFLD);\n* Adult age (≥18 years);\n* Ability to provide written informed consent; Attending the Hepatology Outpatient Unit of IRCCS \"S. de Bellis\"\n\nEsclusion Criteria:\n\n* Liver cirrhosis;\n* Active oncological diseases;\n* Viral hepatitis (HBV, HCV, HIV infection);\n* Severe medical conditions that may compromise study participation","ALL","18 Years",{"count":75,"type":76},24,"ESTIMATED","OBSERVATIONAL","This is a two-arm, prospective, controlled observational pilot clinical study aimed at characterizing the lipidomic profile and extracellular vesicles (EVs) of patients with autoimmune hepatitis (AIH) compared to patients with non-alcoholic fatty liver disease (NAFLD). A total of 24 adult outpatients will be enrolled at the Hepatology Outpatient Unit of IRCCS \"S. de Bellis\". Blood samples will be collected by venipuncture to perform lipidomic analyses on red blood cell membranes and serum, and to isolate and characterize EVs. No intervention beyond standard clinical practice will be applied",[80,81],"Autoimmune Hepatitis","Non-Alcoholic Fatty Liver Disease",[83,84,85,86,87,88],"autoimmune hepatitis","lipidomic analysis","extracellular vesicles","fatty acids","biomarkers","NAFLD","NOT_YET_RECRUITING","2026-06-15",{"date":92,"type":93},"2026-06-16","ACTUAL",{"date":95,"type":76},"2026-07-01",{"date":97,"type":76},"2028-07-01",{"name":5,"class":6},1]