An observational study in Exocrine Pancreatic Insufficiency, Fatty Liver, Nonalcoholic and Pancreatic Steatosis, sponsored by Maria Marta Piskorz. Not yet recruiting at 1 site in Argentina. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-06.
Sponsored by Maria Marta Piskorz · Observational
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).
The purpose of this study is to evaluate the association between non-alcoholic fatty liver disease and non-alcoholic pancreatic steatosis and to describe cytokine levels in the context of a global epidemic of obesity and metabolic syndrome, which could represent a new treatment target in previously underdiagnosed patients with pancreatic insufficiency and pancreatic steatosis.
Patients over 18 years old with a diagnosis of MAFLD (Metabolic Dysfunction-Associated Fatty Liver Disease) will undergo the following assessments:
Additionally, for those patients with fecal elastase levels below 200 µg/g, the following measurements will be conducted:
For those with exocrine pancreatic insufficiency (EPI):
128 studies on the registry are indexed under Exocrine Pancreatic Insufficiency; 27 are open to participants now.
This study's planned enrollment of 61 is below the median of 115 across 35 observational studies indexed under Exocrine Pancreatic Insufficiency.
Browse Exocrine Pancreatic Insufficiency studies →Maria Marta Piskorz is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients over 18 years old with a diagnosis of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).
Exclusion Criteria:
\*\*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.
\*\*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 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.
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).
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
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
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
Clinical characteristics
Analyze the causes of exocrine pancreatic insufficiency (EPI) and Non-Alcoholic Fatty Pancreas Disease (NAFPD) in this population.
Time frame: At baseline
Cytokine profile
Evaluate the cytokine phenotypic profile in this population.
Time frame: At baseline
Plan to share: Undecided — The data sets, including the redacted study protocol, redacted statistical analysis plan, and individual participant data supporting the results reported in this article, will be made available within 3 months from initial request to researchers who provide a methodologically sound proposal. The data will be provided after its de-identification, in compliance with applicable privacy laws, data protection, and requirements for consent and anonymization.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Exocrine Pancreatic Insufficiency→
Maria Marta Piskorz