Fatty Liver and Pancreatic Steatosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Identification of a Score for the Assessment of Intrapancreatic Fat

NCT07155473

Pancreatic Steatosis Metabolic Syndrome X Diabetes

RECRUITING NA

Dynamic Changes and Risk Factors of Fibrosis and Steatosis Progression in Nonalcoholic Fatty Liver Disease

NCT03635541

Non-Alcoholic Fatty Liver Disease

UNKNOWN

Metabolic Associated Fatty Liver Disease and Pancreatic Steatosis in Obese Versus Lean Chronic Hepatitis B Patients

NCT07175688

Metabolic Associated Fatty Liver Disease Pancreatic Steatosis Obese +2 more

COMPLETED

Screening for Pancreatic Exocrine Insufficieny in Metabolic Associated Fatty Liver Disease Patients

NCT05804409

Pancreatic Exocrine Insufficiency

UNKNOWN

Study for the Identification of a Score to Assess Intrapancreatic Fat Through Eco-Elastography and Its Correlation with Metabolic Syndrome and Insulin-Secreting Cells.

NCT06801769

Pancreatic Steatosis Metabolic Syndrome X Diabetes Mellitus

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Exocrine Pancreatic Insufficiency Fatty Liver, Nonalcoholic Pancreatic Steatosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

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 (p70), MIP-1β, IL-13, PDGF-BB, IL-15, RANTES, IL-17, TNF-α, IP-10, VEGF, MCP-1 (MCAF).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No