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

2026년 6월 5일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

120

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 중국
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, 중국, 201508

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of differentially abundant plasma lipid species identified by targeted lipidomics (UPLC-MS/MS)
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Number of differentially abundant plasma proteins identified by quantitative proteomics
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Yinzhong Shen

수사관

  • 수석 연구원: Yinzhong Shen, Shanghai Public Health Clinical Center, Shanghai, Shanghai 201508

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2026년 9월 1일

연구 완료 (추정된)

2026년 9월 1일

연구 등록 날짜

최초 제출

2026년 5월 31일

QC 기준을 충족하는 최초 제출

2026년 6월 5일

처음 게시됨 (실제)

2026년 6월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 5일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • GKT1341

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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