Lipidomic and Multi-Omics Profiling of Fatty Liver Disease in People With and Without HIV

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorYinzhong Shen

About this trial

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.

Eligibility criteria

Qualifiers

Age 18-80 years

Able to provide written informed consent and cooperate with blood sample collection and clinical data recording

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

Disqualifiers

Chronic liver disease with decompensated cirrhosis, hepatic malignancy, or history of liver transplantation

Pregnancy or lactation

Active severe infectious disease (other than HIV for Group 1)

Severe critical illness or major organ failure

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

120 Participants
are grouped into 3 trial groups

Sponsors and collaborators

Yinzhong Shen

Lead sponsor

Shanghai Public Health Clinical Center

Sponsor institution