[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Yinzhong Shen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100642697","lipidomic-and-multi-omics-profiling-of-fatty-liver-disease-in-people-with-and-without-hiv-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":22,"type":23},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.",[15,27],"HIV (Human Immunodeficiency Virus)",[29,15,30],"HIV","lipidomics","NOT_YET_RECRUITING","2026-06-05",{"date":34,"type":35},"2026-06-11","ACTUAL",{"date":37,"type":23},"2026-06-01",{"date":39,"type":23},"2026-09-01",{"name":41,"class":42},"Yinzhong Shen","OTHER_GOV",""]