Molecular Characterization of Autoimmune Hepatitis: A Lipidomic Approach

Sponsor
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Study ID
NCT07644936
Status
Not Yet Recruiting

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Conditions

  • Autoimmune Hepatitis
  • Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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

Key Dates

First listed
Jun 12, 2026
Start date
Jul 1, 2026
Status verified
Jul 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2028

Study Design

Enrollment
24 participants (estimated)

Arms

  • Arm: 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: 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".

Primary Outcome Measure

Lipidomic profile [ Time Frame: At enrollment (single time point - baseline blood draw) ]

Central Contacts

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