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Molecular Characterization of Autoimmune Hepatitis: A Lipidomic Approach

ConditionsAutoimmune HepatitisNon-Alcoholic Fatty Liver Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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"

Disqualifiers

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"

Liver cirrhosis;

Trial population

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

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

24 Participants
are grouped into 2 trial groups
Group A: Arm A - Autoimmune Hepatitis (AIH)
Group B: Arm B - Non-Alcoholic Fatty Liver Disease (NAFLD)

Trial outcomes

Primary outcomes

1

Lipidomic profile

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).

Time frame
At enrollment (single time point - baseline blood draw)

Secondary outcomes

1

Number and size distribution of serum-derived extracellular vesicles assessed by nanoparticle tracking analysis (NTA)

Isolation and characterization of EVs from patient serum to evaluate their use as biocompatible nanovectors for immunosuppressive/immunomodulatory drug delivery

Time frame
At enrollment (single time point - baseline blood draw)
2

Concentration of serum lipidomic and biochemical biomarkers for AIH diagnosis assessed by integrated lipidomic and biochemical analysis

Identification of molecular biomarkers for early and accurate AIH diagnosis through integrated lipidomic and biochemical analysis

Time frame
At enrollment (single time point - baseline blood draw)
3

Expression profile of EV-associated proteins and miRNAs involved in AIH pathogenesis assessed by proteomic and transcriptomic analysis

Identification of molecular pathways involved in AIH pathogenesis through EV characterization

Time frame
At enrollment (single time point - baseline blood draw)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: