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Molecular Characterization of Autoimmune Hepatitis: A Lipidomic Approach (AIH-LIPID)

14 juli 2026 uppdaterad av: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Molecular Characterization of Autoimmune Hepatitis Through Lipidomic Analysis and Extracellular Vesicle Profiling: A Controlled Pilot Clinical Study

This is a two-arm, prospective, controlled observational pilot clinical study aimed at characterizing the lipidomic profile and extracellular vesicles (EVs) of patients with autoimmune hepatitis (AIH) compared to patients with non-alcoholic fatty liver disease (NAFLD). A total of 24 adult outpatients will be enrolled at the Hepatology Outpatient Unit of IRCCS "S. de Bellis". Blood samples will be collected by venipuncture to perform lipidomic analyses on red blood cell membranes and serum, and to isolate and characterize EVs. No intervention beyond standard clinical practice will be applied

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: Maria Notarnicola, biologyst
Telefonnummer: +39 0804994623
E-post: maria.notarnicola@irccsdebellis.it

Studera Kontakt Backup

Namn: Valentina De Nunzio
Telefonnummer: +39 0804994623
E-post: valentina.denunzio@irccsdebellis.it

Studieorter

Italien
- Bari
  - Castellana Grotte, Bari, Italien, 70013
    - IRCCS "S. de Bellis" - Nutritional Biochemistry Lab
    - Kontakt:
      
      Maria Notarnicola, Biologyst
      
      Telefonnummer: 0804994623
      
      E-post: maria.notarnicola@irccsdebellis.it
    - Kontakt:
      
      Valentina De Nunzio
      
      Telefonnummer: 0804994623
      
      E-post: valentina.denunzio@irccsdebellis.it
    - Huvudutredare:
      
      Maria Notarnicola
    - Underutredare:
      
      Emanuela Aloisio Caruso
    - Underutredare:
      
      Valentina De Nunzio
    - Underutredare:
      
      Giuliano Pinto
    - Underutredare:
      
      Angela Tafaro
    - Underutredare:
      
      Maria Principia Scavo
    - Underutredare:
      
      Raffaele Cozzolongo
    - Underutredare:
      
      Endrit Shahini
    - Underutredare:
      
      Pasqua Letizia Pesole

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

dult outpatients with AIH or NAFLD diagnosis attending the UOSD Epatopatie at IRCCS "S. de Bellis", Castellana Grotte (BA), Italy

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
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".
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".

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Lipidomic profile Tidsram: At enrollment (single time point - baseline blood draw)	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).	At enrollment (single time point - baseline blood draw)

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Number and size distribution of serum-derived extracellular vesicles assessed by nanoparticle tracking analysis (NTA) Tidsram: At enrollment (single time point - baseline blood draw)	Isolation and characterization of EVs from patient serum to evaluate their use as biocompatible nanovectors for immunosuppressive/immunomodulatory drug delivery	At enrollment (single time point - baseline blood draw)
Concentration of serum lipidomic and biochemical biomarkers for AIH diagnosis assessed by integrated lipidomic and biochemical analysis Tidsram: At enrollment (single time point - baseline blood draw)	Identification of molecular biomarkers for early and accurate AIH diagnosis through integrated lipidomic and biochemical analysis	At enrollment (single time point - baseline blood draw)
Expression profile of EV-associated proteins and miRNAs involved in AIH pathogenesis assessed by proteomic and transcriptomic analysis Tidsram: At enrollment (single time point - baseline blood draw)	Identification of molecular pathways involved in AIH pathogenesis through EV characterization	At enrollment (single time point - baseline blood draw)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juli 2026

Primärt slutförande (Beräknad)

1 juli 2027

Avslutad studie (Beräknad)

1 juli 2028

Studieregistreringsdatum

Först inskickad

8 juni 2026

Först inskickad som uppfyllde QC-kriterierna