Blood fat and protein patterns in fatty liver disease, with and without HIV
Compares blood samples from adults with fatty liver disease, with or without HIV.
Plain-language title generated from the registry record
Registry title: Lipidomic and Multi-Omics Profiling of Fatty Liver Disease in People With and Without HIV
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07640880, who can take part
Where in China
- Shanghai Public Health Clinical CenterShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Yinzhong Shen
- Trial code
- NCT07640880
- Record updated
- 11 June 2026
- Original description
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.Read full original descriptionShow less
Multi-Omics Characterization of Lipid Metabolic Reprogramming in People With HIV Versus HIV-Negative Metabolic Dysfunction-Associated Steatotic Liver Disease
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.
This 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.
Findings 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.
Inclusion: Age 18-80 years; Able to provide written informed consent and cooperate with blood sample collection and clinical data recording; For Group 1 (Treatment-naive people with HIV and MASLD):; Confirmed HIV infection with no prior antiretroviral therapy (treatment-naive); 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/week for men, >140 g/week for women), and at least one metabolic cardiovascular risk factor; For Group 2 (HIV-negative individuals with MASLD):; HIV-negative; Diagnosis of MASLD as defined above; For Group 3 (Healthy Controls):; HIV-negative; Normal liver morphology on abdominal ultrasonography within the past year, with no evidence of hepatic steatosis; Matched to MASLD groups by age (within 5 years), sex, and BMI (within 3 kg/m²).
Exclusion: Chronic liver disease with decompensated cirrhosis, hepatic malignancy, or history of liver transplantation; Active severe infectious disease (other than HIV for Group 1); Severe critical illness or major organ failure; Pregnancy or lactation.