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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Lipidomic profile — 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).
Trial sites (1)
Facility
City
Region
Status
IRCCS "S. de Bellis" - Nutritional Biochemistry Lab
Castellana Grotte
Bari
More Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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