Clinical trial NCT06757348: Fatty Liver and Pancreatic Steatosis
Official title: Association Between Fatty Liver and Pancreatic Steatosis in Patients With Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Exocrine Pancreatic Insufficiency
Fatty Liver, Nonalcoholic
Pancreatic Steatosis
Keywords: Fatty liver
Pancreatic steatosis
Metabolic syndrome
Lead sponsor: Hospital de Clinicas José de San Martín
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years old with a diagnosis of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).

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

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence Non-Alcoholic Fatty Pancreas Disease
timeFrame: At baseline
measure: Prevalence of exocrine pancreatic insufficiency
timeFrame: At baseline
measure: Prevalence of IPE in MAFLD
timeFrame: At baseline
Secondary outcomes:
measure: Clinical characteristics
timeFrame: At baseline
measure: Cytokine profile
timeFrame: At baseline
Other outcomes:
Locations:
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital de Clinicas Jose de San Martin
state: Buenos Aires
Study officials:
References:
citation: Olmos JI, Piskorz MM, Litwin N, Schaab S, Tevez A, Bravo-Velez G, Uehara T, Hashimoto H, Rey E, Sorda JA, Olmos JA. Exocrine Pancreatic Insufficiency is Undiagnosed in Some Patients with Diarrhea-Predominant Irritable Bowel Syndrome Using the Rome IV Criteria. Dig Dis Sci. 2022 Dec;67(12):5666-5675. doi: 10.1007/s10620-022-07568-8. Epub 2022 Jun 15.
citation: Bellentani S. The epidemiology of non-alcoholic fatty liver disease. Liver Int. 2017 Jan;37 Suppl 1:81-84. doi: 10.1111/liv.13299.
citation: Bedogni G, Miglioli L, Masutti F, Castiglione A, Croce LS, Tiribelli C, Bellentani S. Incidence and natural course of fatty liver in the general population: the Dionysos study. Hepatology. 2007 Nov;46(5):1387-91. doi: 10.1002/hep.21827.
citation: Weiss J, Rau M, Geier A. Non-alcoholic fatty liver disease: epidemiology, clinical course, investigation, and treatment. Dtsch Arztebl Int. 2014 Jun 27;111(26):447-52. doi: 10.3238/arztebl.2014.0447.
citation: Eslam M, Sanyal AJ, George J; International Consensus Panel. MAFLD: A Consensus-Driven Proposed Nomenclature for Metabolic Associated Fatty Liver Disease. Gastroenterology. 2020 May;158(7):1999-2014.e1. doi: 10.1053/j.gastro.2019.11.312. Epub 2020 Feb 8.
citation: Eslam M, Newsome PN, Sarin SK, Anstee QM, Targher G, Romero-Gomez M, Zelber-Sagi S, Wai-Sun Wong V, Dufour JF, Schattenberg JM, Kawaguchi T, Arrese M, Valenti L, Shiha G, Tiribelli C, Yki-Jarvinen H, Fan JG, Gronbaek H, Yilmaz Y, Cortez-Pinto H, Oliveira CP, Bedossa P, Adams LA, Zheng MH, Fouad Y, Chan WK, Mendez-Sanchez N, Ahn SH, Castera L, Bugianesi E, Ratziu V, George J. A new definition for metabolic dysfunction-associated fatty liver disease: An international expert consensus statement. J Hepatol. 2020 Jul;73(1):202-209. doi: 10.1016/j.jhep.2020.03.039. Epub 2020 Apr 8.
citation: Dominguez-Munoz JE. Diagnosis and treatment of pancreatic exocrine insufficiency. Curr Opin Gastroenterol. 2018 Sep;34(5):349-354. doi: 10.1097/MOG.0000000000000459.