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

Not Yet RecruitingN/A

Sponsor: Yinzhong Shen

Conditions: MASLD, HIV (Human Immunodeficiency Virus)

Countries: China

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 overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Locations (1)

Shanghai, Shanghai Municipality, China