Fatty Liver and Pancreatic Steatosis

August 5, 2025 updated by: Maria Marta Piskorz

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1119
        • Hospital de clinicas jose de San Martin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At baseline
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).
At baseline
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).
At baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical characteristics
Time Frame: At baseline
Analyze the causes of exocrine pancreatic insufficiency (EPI) and Non-Alcoholic Fatty Pancreas Disease (NAFPD) in this population.
At baseline
Cytokine profile
Time Frame: At baseline
Evaluate the cytokine phenotypic profile in this population.
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Marta Piskorz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

October 22, 2024

First Submitted That Met QC Criteria

January 1, 2025

First Posted (Actual)

January 3, 2025

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCJSM-11-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data sets, including the redacted study protocol, redacted statistical analysis plan, and individual participant data supporting the results reported in this article, will be made available within 3 months from initial request to researchers who provide a methodologically sound proposal. The data will be provided after its de-identification, in compliance with applicable privacy laws, data protection, and requirements for consent and anonymization.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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