[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642697":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":23,"locations":33,"responsibleParty":51,"collaborators":10,"id":54,"slug":10,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":75,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Shanghai Public Health Clinical Center","OTHER_GOV",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"PWH with MASLD",null,"People with HIV diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD), enrolled from the outpatient clinic of Shanghai Public Health Clinical Center.",{"label":13,"type":10,"description":14,"interventionNames":10},"HIV negative with MASLD","HIV-negative individuals diagnosed with MASLD, enrolled from Shanghai Public Health Clinical Center and affiliated health examination centers.",{"label":16,"type":10,"description":17,"interventionNames":10},"healthy controls","HIV-negative individuals without liver disease, matched to MASLD groups by age, sex, and BMI, enrolled from affiliated health examination centers.",[19],{"name":20,"affiliation":21,"role":22},"Yinzhong Shen","Shanghai Public Health Clinical Center, Shanghai, Shanghai 201508","PRINCIPAL_INVESTIGATOR",[24,29],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Yinzhong Shen, PhD","CONTACT","+8618916113951","shenyinzhong@shphc.org.cn",{"name":30,"role":26,"phone":31,"phoneExt":10,"email":32},"Wei Xu, PhD","+8613660308971","24111300008@m.fudan.edu.cn",[34],{"facility":5,"status":10,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Shanghai","Shanghai Municipality","201508","China","CN",{"type":41,"coordinates":42},"Point",[43,44],121.45806,31.22222,{"lat":44,"lon":43},[47,49],{"name":25,"role":26,"phone":48,"phoneExt":10,"email":28},"+86 18916113951",{"name":30,"role":26,"phone":50,"phoneExt":10,"email":32},"+86 13660308971",{"type":52,"investigatorFullName":20,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Clinical Professor","100642697",false,"NCT07640880","Lipidomic and Multi-Omics Profiling of Fatty Liver Disease in People With and Without HIV","Multi-Omics Characterization of Lipid Metabolic Reprogramming in People With HIV Versus HIV-Negative Metabolic Dysfunction-Associated Steatotic Liver Disease","MASLD","Inclusion Criteria:\n\n* Age 18-80 years\n* Able to provide written informed consent and cooperate with blood sample collection and clinical data recording\n\nFor Group 1 (Treatment-naive people with HIV and MASLD):\n\n* Confirmed HIV infection with no prior antiretroviral therapy (treatment-naive)\n* Diagnosis of MASLD per the 2024 Chinese Guidelines: hepatic steatosis confirmed by imaging or histology (≥5% macrovesicular steatosis), exclusion of excessive alcohol consumption (\\>210 g\u002Fweek for men, \\>140 g\u002Fweek for women), and at least one metabolic cardiovascular risk factor\n\nFor Group 2 (HIV-negative individuals with MASLD):\n\n* HIV-negative\n* Diagnosis of MASLD as defined above\n\nFor Group 3 (Healthy Controls):\n\n* HIV-negative\n* Normal liver morphology on abdominal ultrasonography within the past year, with no evidence of hepatic steatosis\n* Matched to MASLD groups by age (within 5 years), sex, and BMI (within 3 kg\u002Fm²)\n\nExclusion Criteria:\n\n* Chronic liver disease with decompensated cirrhosis, hepatic malignancy, or history of liver transplantation\n* Pregnancy or lactation\n* Active severe infectious disease (other than HIV for Group 1)\n* Severe critical illness or major organ failure",true,"ALL","18 Years","80 Years",{"count":66,"type":67},120,"ESTIMATED","OBSERVATIONAL","Metabolic dysfunction-associated steatotic liver disease (MASLD), commonly known as fatty liver disease, is increasingly prevalent worldwide. People living with HIV (PWH) face a higher risk of developing MASLD due to chronic immune activation and long-term antiretroviral therapy, yet whether the underlying biological changes differ from those in HIV-negative individuals with MASLD remains unknown.\n\nThis prospective observational study will enroll three groups: PWH with MASLD, HIV-negative individuals with MASLD, and healthy controls without liver disease. A single fasting blood sample will be collected from each participant. Using targeted lipidomics, proteomics, and transcriptomics platforms, researchers will compare plasma molecular profiles across the three groups to identify MASLD-specific lipid signatures, characterize metabolic pathway dysregulation, and discover potential blood-based biomarkers for non-invasive diagnosis of MASLD.\n\nFindings from this study may help explain how HIV infection alters lipid metabolism in the context of MASLD and support the development of HIV-specific diagnostic tools for fatty liver disease.",[59,71],"HIV (Human Immunodeficiency Virus)",[73,59,74],"HIV","lipidomics","NOT_YET_RECRUITING","2026-06-05",{"date":78,"type":79},"2026-06-11","ACTUAL",{"date":81,"type":67},"2026-06-01",{"date":83,"type":67},"2026-09-01",{"name":20,"class":6},1]