[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544098":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":18,"centralContacts":31,"locations":10,"responsibleParty":37,"collaborators":10,"id":40,"slug":10,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":10,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":52,"studyType":53,"phases":10,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":60,"whyStopped":10,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":10},{"fullName":5,"class":6},"Beijing Friendship Hospital","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Observational group of NASH-related liver fibrosis",null,[12],"Other: lifestyle intervention",[14],{"type":6,"name":15,"description":16,"armGroupLabels":17,"otherNames":10},"lifestyle intervention","Dietary recommendations should consider energy restriction and exclusion of MAFLD-mediating components (processed food, food and beverages high in added fructose). A Mediterranean type diet is advisable. Both aerobic exercise and resistance training effectively reduce liver fat and should be tailored based on patient preferences to ensure long-term adherence.",[9],[19,22,25,28],{"name":20,"affiliation":5,"role":21},"Jidong Jia, Professor","PRINCIPAL_INVESTIGATOR",{"name":23,"affiliation":24,"role":21},"Jingmin Zhao, Professor","Beijing 302 Hospital",{"name":26,"affiliation":27,"role":21},"Jing Zhang","Beijing You-an Hospital, Capital Medical University",{"name":29,"affiliation":30,"role":21},"Minghui Li","Beijing Ditan Hospital",[32],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},"Yameng Sun, M.D.","CONTACT","86-010-63138656","sunyamenggo@163.com",{"type":21,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Jidong Jia","Principal Investigator","100544098",false,"NCT06364462","Precise Evaluation Criteria for Histological Regression of NASH Fibrosis","Establishment of Precise Evaluation Criteria for Histological Regression of NASH-related Liver Fibrosis","Inclusion Criteria:\n\n* 18-70 years of age.\n* Liver biopsy-proven NASH fibrosis with stage F2-4.\n* Signature of written informed consent.\n\nExclusion Criteria:\n\n* Patients with other liver diseases, including viral hepatitis, alcoholic liver diseases, autoimmune liver diseases, genetic metabolic liver disease, drug-induced liver diseases, and infected with HIV.\n* Pregnant women.\n* Patients have the following conditions before liver biopsy:\n\nHepatocellular carcinoma or suspected liver cancer; Decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal variceal bleeding, hepatorenal syndrome; Other malignancy; Undergone liver transplantation surgery;\n\n* Patients with any other reasons not suitable for the study.","ALL","18 Years","75 Years",{"count":50,"type":51},220,"ESTIMATED","3 Years","OBSERVATIONAL","It is an observational study of NASH patients with a calculated sample size of 220. Liver biopsy-proven NASH fibrosis with stage F2-F4 will be recruited in this study. A second biopsy will be performed after clinical trials or 1-3 years of lifestyle intervention. Patients will be followed up at baseline and every six months with h-CRP, liver function tests, fasting blood glucose, fasting insulin, ferritin, liver ultrasonography, and liver stiffness measurements.",[56,57],"NASH","Liver Fibrosis",[56,59],"Liver fibrosis","NOT_YET_RECRUITING","2024-05-27",{"date":63,"type":64},"2024-05-29","ACTUAL",{"date":66,"type":51},"2024-06-15",{"date":68,"type":51},"2027-04-01",{"name":5,"class":6}]