[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644359":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":10,"responsibleParty":21,"collaborators":10,"id":25,"slug":26,"hasResults":27,"nctId":28,"briefTitle":29,"officialTitle":30,"acronym":31,"eligibilityCriteria":32,"healthyVolunteers":27,"sex":33,"minAge":34,"maxAge":35,"enrollmentInfo":36,"targetDuration":10,"studyType":39,"phases":10,"briefSummary":40,"conditions":41,"keywords":43,"overallStatus":45,"whyStopped":10,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":10},{"fullName":5,"class":6},"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"High FIB-4",null,"Obese patients with FIB-4 ≥ 1.3 undergoing FibroScan as part of clinical practice.",{"label":13,"type":10,"description":14,"interventionNames":10},"Low FIB-4","Obese patients with FIB-4 \\\u003C 1.3 undergoing FibroScan as part of clinical practice",[16],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Vincenza Di Stasi, MD","CONTACT","+39 0804994669","vincenza.distasi@irccsdebellis.it",{"type":22,"investigatorFullName":23,"investigatorTitle":24,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Vincenza Di Stasi","MD","100644359","fib-4-cut-offs-for-liver-fibrosis-in-obese-endocrinology-patients-100644359",false,"NCT07663188","FIB-4 Cut-Offs for Liver Fibrosis in Obese Endocrinology Patients","Assessment of the Accuracy of FIB-4 Cut-Offs for the Prediction of Liver Fibrosis in Obese Patients Attending Endocrinology Clinics in Italy","OBEMASLD","Inclusion Criteria:\n\n* Obesity class I or II (body mass index, BMI ≥ 30 kg\u002Fm² and ≤ 40 kg\u002Fm²)\n* Age \\> 18 years and \\\u003C 65 years.\n* Ability to provide written informed consent after adequate information on the study objectives.\n* Arm 1: patients with FIB-4 ≥ 1.3.\n* Arm 2: patients with FIB-4 \\\u003C 1.3.\n\nExclusion Criteria:\n\n* Lack of signed informed consent.\n* Pregnancy or breastfeeding.\n* Known liver diseases that rule out MASLD (MetALD, alcoholic liver disease, liver cirrhosis, hepatocellular carcinoma, viral hepatitis, autoimmune hepatitis).\n* Current treatment with anti-obesity or type 2 diabetes medications with a known effect on hepatic steatosis (Semaglutide or Tirzepatide).","ALL","18 Years","65 Years",{"count":37,"type":38},400,"ESTIMATED","OBSERVATIONAL","This single-center, prospective observational study aims to assess the accuracy of FIB-4 cut-offs in identifying liver fibrosis in obese patients attending an endocrinology outpatient clinic in Italy.\n\nAll consecutive eligible patients undergo routine blood tests and liver elastography (FibroScan) as part of clinical practice; FIB-4 values will be calculated and compared with liver stiffness measurements to evaluate the performance of FIB-4 thresholds for directing patients to FibroScan and hepatology care.",[42],"MASLD",[42,44],"FIB-4","NOT_YET_RECRUITING","2026-06-17",{"date":48,"type":49},"2026-06-23","ACTUAL",{"date":51,"type":38},"2026-09-01",{"date":53,"type":38},"2028-09-01",{"name":5,"class":6}]