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Clinical Trials in China / NCT07640880
Starting soon Observational

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

NCT07640880 · tracked via the Priya Life Science China tracker
Sponsor
Yinzhong Shen
Phase
Observational
Started
2026-06-01
Last updated
2026-06-11

Condition(s) studied

MASLDHIV (Human Immunodeficiency Virus)

Study summary

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Number of differentially abundant plasma lipid species identified by targeted lipidomics (UPLC-MS/MS) — At enrollment (single time point, cross-sectional)
    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.

Trial sites (1)

FacilityCityRegionStatus
Shanghai Public Health Clinical Center Shanghai Shanghai Municipality

Other trials for the same condition

Digital Early Warning System for Acute Lung Injury in Liver Surgery Recruiting
Phase II Study Evaluating the Efficacy and Safety of DR10624 Injection in MASLD and MetALD Subjects Active, not recruiting
Integrated Ultrasound-Derived Fat Fraction and 2D/4D HeartAI for Cardiovascular Risk Management in Patients With MASLD Starting soon
A Safety and Efficacy Trial of Chidamide Combined With NKG2D CAR-NK Cell Therapy for Reducing the HIV Viral Reservoir Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07640880 on ClinicalTrials.gov ↗ ← All trials in China