Health TrialsbyHealthPanel

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

ConditionsMASLDHIV (Human Immunodeficiency Virus)
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

This trial accepts healthy volunteers

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 population

Participants are recruited from a single tertiary hospital (Shanghai Public Health Clinical Center): (1) treatment-naive people with HIV and MASLD from the outpatient Department of Infection and Immunity; (2) HIV-negative individuals with MASLD identified through the hospital's Health Management Center; and (3) healthy controls without liver disease from the same Health Management Center, matched to MASLD groups by age, sex, and BMI.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 3 trial groups
Group A: PWH with MASLD
Group B: HIV negative with MASLD
Group C: healthy controls

Trial outcomes

Primary outcomes

1

Number of differentially abundant plasma lipid species identified by targeted lipidomics (UPLC-MS/MS)

Number of plasma lipid species showing statistically significant differential abundance among the three groups (treatment-naïve people with HIV and MASLD, HIV-negative people with MASLD, and healthy controls). Lipid species across core lipid classes (free fatty acids, ceramides, sphingomyelins, triglycerides, diacylglycerols, and phosphatidylcholines) are quantified by targeted lipidomics using ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) in multiple reaction monitoring (MRM) mode, with quality-control samples and internal standards (e.g., TAG 17:0, Cer d18:1/17:0; RSD \<15%). A lipid species is counted as differentially abundant if it meets fold change ≥1.5 or ≤0.67, and FDR \<0.05.

Time frame
At enrollment (single time point, cross-sectional)

Secondary outcomes

1

Number of differentially abundant plasma proteins identified by quantitative proteomics

Number of plasma proteins showing statistically significant differential abundance among the three groups (treatment-naïve people with HIV and MASLD, HIV-negative people with MASLD, and healthy controls), quantified by mass spectrometry-based (DIA) proteomics. A protein is counted as differentially abundant if it meets \|log2 fold change\| \>1 and adjusted p \<0.05.

Time frame
At enrollment
2

Number of differentially expressed genes in PBMCs identified by RNA sequencing

Number of genes showing statistically significant differential expression in peripheral blood mononuclear cells (PBMCs) among the three groups (treatment-naïve people with HIV and MASLD, HIV-negative people with MASLD, and healthy controls), quantified by RNA sequencing. A gene is counted as differentially expressed if it meets \|log2 fold change\| \>1 and FDR \<0.05.

Time frame
At enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yinzhong Shen

Lead sponsor

Shanghai Public Health Clinical Center

Sponsor institution

Source ClinicalTrials.gov

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