Fatty Liver and Pancreatic Steatosis
NCT06757348 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 61
Last updated 2025-08-06
Summary
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).
Conditions
- Exocrine Pancreatic Insufficiency
- Fatty Liver, Nonalcoholic
- Pancreatic Steatosis
Interventions
- DIAGNOSTIC_TEST
-
Fecal elastase
\*\*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.
- DIAGNOSTIC_TEST
-
Ecoendoscopy
\*\*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.
- DIAGNOSTIC_TEST
-
Fibroscan
\*\*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.
- DIAGNOSTIC_TEST
-
Serum cytokines
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).
Sponsors & Collaborators
-
Maria Marta Piskorz
lead OTHER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-01
- Primary Completion
- 2026-03-01
- Completion
- 2026-03-01
Countries
- Argentina
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