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

5. Juni 2026 aktualisiert von: Yinzhong Shen

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

MASLD is characterized by hepatic lipid accumulation driven by metabolic dysfunction, and its pathophysiology involves extensive lipid metabolic reprogramming - including dysregulation of triglycerides, diacylglycerols, ceramides, and phosphatidylcholines. In people living with HIV (PWH), the metabolic burden imposed by chronic immune activation and long-term antiretroviral therapy (ART) further disrupts circulating lipid homeostasis, potentially creating a distinct pathophysiological profile compared to HIV-negative individuals with MASLD. However, the molecular differences between HIV-associated and HIV-negative MASLD have not been systematically characterized.

This prospective, observational, cross-sectional study enrolls three groups: (1) PWH with MASLD, (2) HIV-negative individuals with MASLD, and (3) healthy controls matched for age, sex, and BMI. All participants are recruited from Shanghai Public Health Clinical Center and affiliated health examination centers. A single fasting peripheral blood sample (10 mL) is collected from each participant, from which plasma is isolated and stored at -80°C until analysis.

Plasma samples will undergo multi-omics profiling including:

Targeted lipidomics: quantitative analysis of core lipid classes (free fatty acids, ceramides, sphingomyelins, triglycerides, diacylglycerols, phosphatidylcholines) using UPLC-MS/MS in multiple reaction monitoring (MRM) mode Proteomics: plasma protein profiling to identify disease-associated protein expression changes Transcriptomics: gene expression analysis to characterize transcriptional alterations associated with MASLD in the context of HIV infection Differential lipid features will be identified using multivariate analysis (PCA, OPLS-DA) and univariate filtering (VIP > 1, |FC| > 1.5, FDR < 0.05). KEGG and LipidMaps pathway enrichment analyses will reveal key metabolic pathways involved in lipid reprogramming. Correlations between lipid signatures and clinical parameters will be examined using Spearman correlation analysis. ROC curve analysis and logistic regression will be used to evaluate the diagnostic performance of candidate biomarkers.

This study aims to: (1) establish a comprehensive plasma lipidomic and multi-omics atlas of MASLD in PWH versus HIV-negative individuals; (2) identify HIV-specific lipid dysregulation patterns; and (3) discover novel, non-invasive biomarkers for MASLD diagnosis applicable to the HIV-infected population.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

120

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201508

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
PWH with MASLD
People with HIV diagnosed with metabolic dysfunction-associated steatotic liver disease (MASLD), enrolled from the outpatient clinic of Shanghai Public Health Clinical Center.
HIV negative with MASLD
HIV-negative individuals diagnosed with MASLD, enrolled from Shanghai Public Health Clinical Center and affiliated health examination centers.
healthy controls
HIV-negative individuals without liver disease, matched to MASLD groups by age, sex, and BMI, enrolled from affiliated health examination centers.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of differentially abundant plasma lipid species identified by targeted lipidomics (UPLC-MS/MS)
Zeitfenster: 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.
At enrollment (single time point, cross-sectional)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of differentially abundant plasma proteins identified by quantitative proteomics
Zeitfenster: At enrollment
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.
At enrollment
Number of differentially expressed genes in PBMCs identified by RNA sequencing
Zeitfenster: At enrollment
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.
At enrollment

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Yinzhong Shen

Ermittler

  • Hauptermittler: Yinzhong Shen, Shanghai Public Health Clinical Center, Shanghai, Shanghai 201508

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. September 2026

Studienabschluss (Geschätzt)

1. September 2026

Studienanmeldedaten

Zuerst eingereicht

31. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Juni 2026

Zuerst gepostet (Tatsächlich)

11. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • GKT1341

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data will not be shared publicly to protect the privacy and confidentiality of people living with HIV, given the sensitive nature of HIV status and the potential risk of participant re-identification in this population. De-identified data may be made available from the corresponding author upon reasonable request and with appropriate ethical approval.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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