Fatty Liver and Pancreatic Steatosis

Официальное название

Association Between Fatty Liver and Pancreatic Steatosis in Patients With Metabolic Syndrome

Обзор

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).

Подробное описание

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

Вмешательства

• Диагностический тест 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 conce
• Диагностический тест 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.
• Диагностический тест 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.
• Диагностический тест 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 (

Первичные конечные точки

• Prevalence Non-Alcoholic Fatty Pancreas Disease [Срок оценки: At baseline]
• Prevalence of exocrine pancreatic insufficiency [Срок оценки: At baseline]
• Prevalence of IPE in MAFLD [Срок оценки: At baseline]

Вторичные конечные точки (2)

• Clinical characteristics [Срок оценки: At baseline]
• Cytokine profile [Срок оценки: At baseline]

Критерии участия

Критерии включения

• Patients over 18 years old with a diagnosis of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).

Критерии исключения

• \- 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Аргентина · 1 центр

• Hospital de Clinicas Jose de San Martin — Ciudad Autonoma de Buenos Aires

Публикации

• 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. PMID 35704255
• Bellentani S. The epidemiology of non-alcoholic fatty liver disease. Liver Int. 2017 Jan;37 Suppl 1:81-84. doi: 10.1111/liv.13299. PMID 28052624
• 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. PMID 17685472
• 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. PMID 25019921
• 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. PMID 32044314
• 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 m PMID 32278004
• Dominguez-Munoz JE. Diagnosis and treatment of pancreatic exocrine insufficiency. Curr Opin Gastroenterol. 2018 Sep;34(5):349-354. doi: 10.1097/MOG.0000000000000459. PMID 29889111

Идентификаторы

NCT: NCT06757348 · HCJSM-11-2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗