Exocrine Pancreatic Insufficiency, Fatty Liver, Nonalcoholic, Pancreatic Steatosis
Conditions
Keywords
Fatty liver, Pancreatic steatosis, Metabolic syndrome
Brief 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).
Detailed description
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: * Exocrine Pancreatic Insufficiency Questionnaire (PEI-Q) * Measurement of weight, height, and abdominal circumference * Fecal elastase (Fel-1) * Pro-inflammatory and anti-inflammatory cytokines in serum * Hydrogen and methane breath tests to evaluate small intestinal bacterial overgrowth (SIBO) * Endoscopic ultrasound with sedation * Fibroscan Exocrine pancreatic insufficiency (EPI) will be defined as a fecal elastase-1 (Fel-1) concentration of \< 100 µg/g or Fel-1 between 100 and 200 µg/g with alterations in additional pancreatic pathology tests, such as serum albumin, vitamin E, vitamin D, vitamin A, folic acid, iron, transferrin, calcium, magnesium, and/or malnutrition identified through anthropometric measurements conducted by an expert nutritionist. Fel-1 ≥ 200 µg/g will be considered normal. Additionally, for those patients with fecal elastase levels below 200 µg/g, the following measurements will be conducted: * Proteinogram * Vitamin E, vitamin D, vitamin A, vitamin K * Folic acid, B12 * Calcium, magnesium, zinc * Iron profile * Nutritional assessment with anthropometry For those with exocrine pancreatic insufficiency (EPI): * IgG4 * Alpha-1 antitrypsin * Endoscopic ultrasound (EUS) with biopsies
Interventions
DIAGNOSTIC_TESTFecal 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_TESTEcoendoscopy
\*\*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_TESTFibroscan
\*\*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_TESTSerum 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
Maria Marta Piskorz
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years old with a diagnosis of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).
Exclusion criteria
* \- 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 * Wilson's disease * Alpha-1 antitrypsin deficiency * Celiac disease * Uncontrolled thyroid disease * Active or chronic infectious disease * Active cancer or ongoing treatment * Chronic renal insufficiency * Pregnancy/lactation * Insufficient data * Patients who do not complete follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence Non-Alcoholic Fatty Pancreas Disease | At baseline | 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 | At baseline | Determine the prevalence of exocrine pancreatic insufficiency (EPI) in patients with Non-Alcoholic Fatty Pancreas Disease (NAFPD). |
| Prevalence of IPE in MAFLD | At baseline | Determine the prevalence of exocrine pancreatic insufficiency (EPI) in patients with Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical characteristics | At baseline | Analyze the causes of exocrine pancreatic insufficiency (EPI) and Non-Alcoholic Fatty Pancreas Disease (NAFPD) in this population. |
| Cytokine profile | At baseline | Evaluate the cytokine phenotypic profile in this population. |
Countries
Argentina
Contacts
Primary ContactMARIA M PISKORZ, MD
Outcome results
None listed