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 volunteersQualifiers
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
Other
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 testPeripheral 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
Trial outcomes
Primary outcomes
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).
Prevalence of exocrine pancreatic insufficiency
Determine the prevalence of exocrine pancreatic insufficiency (EPI) in patients with Non-Alcoholic Fatty Pancreas Disease (NAFPD).
Prevalence of IPE in MAFLD
Determine the prevalence of exocrine pancreatic insufficiency (EPI) in patients with Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).
Secondary outcomes
Clinical characteristics
Analyze the causes of exocrine pancreatic insufficiency (EPI) and Non-Alcoholic Fatty Pancreas Disease (NAFPD) in this population.
Cytokine profile
Evaluate the cytokine phenotypic profile in this population.
Locations
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Sponsors and contacts
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Maria Marta Piskorz
Lead sponsor
Hospital de Clinicas José de San Martín
Sponsor institution
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