Fatty Liver and Pancreatic Steatosis

Not yet recruiting

• Conditions: Exocrine Pancreatic Insufficiency; Fatty Liver, Nonalcoholic; Pancreatic Steatosis

• Registration Number: NCT06757348
• Lead Sponsor: Maria Marta Piskorz

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

Study Timeline

• Study First Submitted: 2024-10-22
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-01
• Last Update Submitted: 2025-01-01
• Study First Posted: 2025-01-03
• Last Update Posted: 2025-01-03
• Study Start: 2025-03-01
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hospital de Clinicas Jose de San Martin; 🇦🇷 Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina