Molecular Characterization of Autoimmune Hepatitis: A Lipidomic Approach (AIH-LIPID)
Molecular Characterization of Autoimmune Hepatitis Through Lipidomic Analysis and Extracellular Vesicle Profiling: A Controlled Pilot Clinical Study
연구 개요
상태
상세 설명
Autoimmune hepatitis (AIH) is a chronic inflammatory liver disease characterized by high serum levels of transaminases and IgG immunoglobulins, presence of organ-specific and non-organ-specific autoantibodies, and interface hepatitis at histopathology. Two distinct types are recognized: AIH type 1, associated with anti-smooth muscle antibodies (SMA) and/or antinuclear antibodies (ANA); and AIH type 2, associated with anti-liver-kidney microsome type 1 (anti-LKM-1) and/or anti-liver cytosol type 1 (anti-LC-1) antibodies.
AIH presents a heterogeneous clinical picture driven by immune dysregulation involving B and T lymphocytes and macrophages. The autoimmune response is initiated by T lymphocyte recognition of self-antigens presented by MHC molecules, leading to differentiation into Th1, Th2, or Th17 cells that mediate hepatic damage.
Extracellular vesicles (EVs) have recently been implicated in AIH pathogenesis, acting as mediators of intercellular communication. EVs can carry autoantigens, signaling molecules, lipids, and nucleic acids, modulating immune responses and potentially facilitating immune tolerance disruption. In AIH, EVs may vehicle hepatic autoantigens and modulate immune cell activity in the liver.
No specific biomarkers currently exist that reliably distinguish AIH from other hepatic conditions, including NAFLD/MASLD, with which it is frequently associated due to overlapping metabolic alterations. A lipidomic approach is therefore proposed to identify specific lipid profiles associated with AIH.
Lipidomic analysis will be performed on red blood cell membranes and serum of both study arms. Extracted fatty acids will be derivatized and analyzed by gas chromatography with flame ionization detection (GC-FID), compared against the FAME Mix-37 chromatogram. EVs isolated from serum will be further characterized for potential use as biocompatible nanovectors for immunosuppressive or immunomodulatory drug delivery.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Maria Notarnicola, biologyst
- 전화번호: +39 0804994623
- 이메일: maria.notarnicola@irccsdebellis.it
연구 연락처 백업
- 이름: Valentina De Nunzio
- 전화번호: +39 0804994623
- 이메일: valentina.denunzio@irccsdebellis.it
연구 장소
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Bari
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Castellana Grotte, Bari, 이탈리아, 70013
- IRCCS "S. de Bellis" - Nutritional Biochemistry Lab
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연락하다:
- Maria Notarnicola, Biologyst
- 전화번호: 0804994623
- 이메일: maria.notarnicola@irccsdebellis.it
-
연락하다:
- Valentina De Nunzio
- 전화번호: 0804994623
- 이메일: valentina.denunzio@irccsdebellis.it
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수석 연구원:
- Maria Notarnicola
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부수사관:
- Emanuela Aloisio Caruso
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부수사관:
- Valentina De Nunzio
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부수사관:
- Giuliano Pinto
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부수사관:
- Angela Tafaro
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부수사관:
- Maria Principia Scavo
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부수사관:
- Raffaele Cozzolongo
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부수사관:
- Endrit Shahini
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부수사관:
- Pasqua Letizia Pesole
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
ARM A:
- Confirmed diagnosis of autoimmune hepatitis (AIH);
- Adult age (≥18 years);
- Ability to provide written informed consent; Attending the Hepatology Outpatient Unit of IRCCS "S. de Bellis"
ARM B:
Exclusion Criteria:
- Confirmed diagnosis of non-alcoholic fatty liver disease (NAFLD);
- Adult age (≥18 years);
- Ability to provide written informed consent; Attending the Hepatology Outpatient Unit of IRCCS "S. de Bellis"
Esclusion Criteria:
- Liver cirrhosis;
- Active oncological diseases;
- Viral hepatitis (HBV, HCV, HIV infection);
- Severe medical conditions that may compromise study participation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Arm A - Autoimmune Hepatitis (AIH)
12 adult outpatients with a confirmed diagnosis of autoimmune hepatitis (AIH), attending the Hepatology Outpatient Unit (UOSD Epatopatie) of IRCCS "S. de Bellis".
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Arm B - Non-Alcoholic Fatty Liver Disease (NAFLD)
12 adult outpatients with a confirmed diagnosis of non-alcoholic fatty liver disease (NAFLD), attending the Hepatology Outpatient Unit (UOSD Epatopatie) of IRCCS "S. de Bellis".
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Lipidomic profile
기간: At enrollment (single time point - baseline blood draw)
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Identification of specific lipid profiles (fatty acid composition) on red blood cell membranes and serum associated with AIH compared to NAFLD, assessed by gas chromatography with flame ionization detection (GC-FID).
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At enrollment (single time point - baseline blood draw)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Extracellular vesicle characterization
기간: At enrollment (single time point - baseline blood draw)
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Isolation and characterization of EVs from patient serum to evaluate their use as biocompatible nanovectors for immunosuppressive/immunomodulatory drug delivery
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At enrollment (single time point - baseline blood draw)
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Autoimmune biomarkers
기간: At enrollment (single time point - baseline blood draw)
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Identification of molecular biomarkers for early and accurate AIH diagnosis through integrated lipidomic and biochemical analysis
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At enrollment (single time point - baseline blood draw)
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Molecular pathways in AIH pathogenesis
기간: At enrollment (single time point - baseline blood draw)
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Identification of molecular pathways involved in AIH pathogenesis through EV characterization
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At enrollment (single time point - baseline blood draw)
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Muratori L, Lohse AW, Lenzi M. Diagnosis and management of autoimmune hepatitis. BMJ. 2023 Feb 6;380:e070201. doi: 10.1136/bmj-2022-070201.
- Nishikawa H, Kim SK, Asai A. Autoimmune Hepatitis and Drug-Induced Liver Injury in Japan. J Clin Med. 2025 Jun 25;14(13):4514. doi: 10.3390/jcm14134514.
- Longhi MS, Zhang L, Mieli-Vergani G, Vergani D. Can we cure autoimmune hepatitis? Curr Opin Immunol. 2025 Oct;96:102609. doi: 10.1016/j.coi.2025.102609. Epub 2025 Jul 14.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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