Fatty Liver and Pancreatic Steatosis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorMaria Marta Piskorz

About this trial

The goal of this observational study is to determine the prevalence of pancreatic steatosis in patients with fatty liver and determine the prevalence of exocrine pancreatic insufficiency (EPI) in these patients.

Participants with fatty liver and metabolic syndrome will undergo fecal elastase measurement and endoscopic ultrasound (EUS).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients over 18 years old with a diagnosis of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).

Disqualifiers

- Alcohol consumption >20 g/day in women, >30 g/day in men

Chronic hepatitis B or C infection

Autoimmune liver diseases: autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis

Hereditary hemochromatosis

Trial population

Patients over 18 years old with a diagnosis of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • Fecal elastase

    Diagnostic test

    \*\*Stool Samples\*\* To investigate exocrine pancreatic insufficiency (EPI), a stool sample will be requested from all patients for fecal elastase (Fel-1) analysis. Participants will be instructed to collect their stool sample in a sterile, disposable plastic container and submit it to the Gastroenterology Chemistry Laboratory (Litwin Laboratory) for processing and analysis. Based on previously published reports, samples will be stored refrigerated at 4-8 °C for no more than 48 hours. The concentrations of Fel-1 in all samples will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit (ScheBo-Pancreatic Elastase 1™, Giessen, Germany), and fecal elastase will be extracted and analyzed according to the manufacturer's instructions.

  • Ecoendoscopy

    Diagnostic test

    \*\*Diagnosis of Pancreatic Steatosis\*\* The diagnosis of pancreatic steatosis will be performed using endoscopic ultrasound. A Pentax EG-3870UTK endoscope will be used in conjunction with Hitachi Avius ultrasound equipment. The procedure is performed under anesthesia using propofol.

  • Fibroscan

    Diagnostic test

    \*\*Fibroscan Procedure:\*\* This is a new technique based on the evaluation of liver elasticity or stiffness that allows for the measurement of liver hardness and quantification of liver fibrosis in a simple and completely painless manner using ultrasound. The results are obtained immediately and can be safely repeated periodically.

  • Serum cytokines

    Diagnostic test

    Peripheral blood will be drawn from all participants in the Gastroenterology Division of the Hospital de Clínicas. Samples will be collected in EDTA tubes, centrifuged, and the serum will be frozen at -80 °C until processing. Serum cytokine levels will be measured using a commercial kit (Bio-Plex Pro human cytokine, Bio-Rad Lab., Inc.), which includes a panel of 27 cytokines: FGF basic, Eotaxin, G-CSF, GM-CSF, IFN-γ, IL-1β, IL-1ra, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, MIP-1α, IL-12 (p70), MIP-1β, IL-13, PDGF-BB, IL-15, RANTES, IL-17, TNF-α, IP-10, VEGF, MCP-1 (MCAF).

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Prevalence Non-Alcoholic Fatty Pancreas Disease

Determine the prevalence of Non-Alcoholic Fatty Pancreas Disease (NAFPD) in patients with Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).

Time frame
At baseline
2

Prevalence of exocrine pancreatic insufficiency

Determine the prevalence of exocrine pancreatic insufficiency (EPI) in patients with Non-Alcoholic Fatty Pancreas Disease (NAFPD).

Time frame
At baseline
3

Prevalence of IPE in MAFLD

Determine the prevalence of exocrine pancreatic insufficiency (EPI) in patients with Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).

Time frame
At baseline

Secondary outcomes

1

Clinical characteristics

Analyze the causes of exocrine pancreatic insufficiency (EPI) and Non-Alcoholic Fatty Pancreas Disease (NAFPD) in this population.

Time frame
At baseline
2

Cytokine profile

Evaluate the cytokine phenotypic profile in this population.

Time frame
At baseline

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Hospital de Clinicas Jose de San Martin Status unavailable 1119, Ciudad Autonoma de Buenos Aires, Buenos AiresArgentinaArgentina

Sponsors and contacts

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

Maria Marta Piskorz

Lead sponsor

Hospital de Clinicas José de San Martín

Sponsor institution

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