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NCT Number: NCT06757348

Fatty Liver and Pancreatic Steatosis

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de Clinicas Jose de San Martin

Ciudad Autonoma de Buenos Aires, Buenos Aires, 1119, Argentina

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fecal elastase

Diagnostic Test

**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.

Ecoendoscopy

Diagnostic Test

**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

Diagnostic Test

**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.

Serum cytokines

Diagnostic Test

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).

Primary outcomes

  1. Prevalence Non-Alcoholic Fatty Pancreas Disease

    Time frame: At baseline

    Determine the prevalence of Non-Alcoholic Fatty Pancreas Disease (NAFPD) in patients with Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).

  2. Prevalence of exocrine pancreatic insufficiency

    Time frame: At baseline

    Determine the prevalence of exocrine pancreatic insufficiency (EPI) in patients with Non-Alcoholic Fatty Pancreas Disease (NAFPD).

  3. Prevalence of IPE in MAFLD

    Time frame: At baseline

    Determine the prevalence of exocrine pancreatic insufficiency (EPI) in patients with Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).

Secondary outcomes

  1. Clinical characteristics

    Time frame: At baseline

    Analyze the causes of exocrine pancreatic insufficiency (EPI) and Non-Alcoholic Fatty Pancreas Disease (NAFPD) in this population.

  2. Cytokine profile

    Time frame: At baseline

    Evaluate the cytokine phenotypic profile in this population.

Study contacts

Contact information is provided by the study sponsor or research team.

MARIA M PISKORZ, MD

CONTACT

[email protected]

+5491133192885

Sponsors and collaborators

Lead sponsor

Maria Marta Piskorz

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 3, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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