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Validation of an Ultrasound Score for Fatty Pancreas

20. juli 2026 opdateret af: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Prospective Observational Study for the Validation of an Ultrasound Scoring System for the Assessment of Fatty Pancreas

This prospective observational study aims to validate an ultrasound scoring system for the assessment of fatty pancreas by comparing it with the current reference standard, magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF). The study will also investigate clinical and laboratory parameters associated with fatty pancreas as potential biomarkers of disease severity and evaluate the relationship between pancreatic fat accumulation, glucose tolerance and pancreatic β-cell function.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Fatty pancreas is an increasingly recognized condition associated with obesity and metabolic dysfunction. Although magnetic resonance imaging with proton density fat fraction (MRI-PDFF) is currently considered the reference standard for non-invasive quantification of pancreatic fat, its limited availability and high cost restrict its routine clinical use. Conventional abdominal ultrasonography is widely available, inexpensive, and easily repeatable, but standardized and validated methods for the assessment of pancreatic steatosis are lacking.The primary objective of this prospective observational study is to validate an ultrasound scoring system for the assessment of fatty pancreas by comparing ultrasound findings with pancreatic fat quantification obtained by MRI-PDFF. In addition, the study aims to identify clinical and laboratory parameters associated with pancreatic steatosis that may serve as non-invasive biomarkers of disease severity and facilitate disease monitoring.The secondary objective is to evaluate the association between the degree of fatty pancreas and glucose metabolism, including glucose tolerance status and pancreatic β-cell function, in order to better characterize the metabolic consequences of pancreatic fat accumulation.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

36

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Italien
      • Roma, Italien, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study will enroll adult male and female patients aged 18-65 years who are referred to the Pancreatic Diseases Unit with a hyperechoic pancreas on abdominal ultrasound.

Beskrivelse

Inclusion Criteria:

  • Male or female patients aged 18 to 65 years.
  • Diagnosis of fatty pancreas confirmed by magnetic resonance imaging (MRI).
  • Adequate pancreatic visualization on abdominal ultrasound, defined as visualization of at least 50% of the pancreatic parenchyma.
  • Provision of written informed consent, signed and dated prior to study enrollment.
  • Ability to understand the nature of the study and to comply with all study procedures and protocol requirements.

Exclusion Criteria:

  • Age <18 years or >65 years.
  • Any psychiatric condition, cognitive impairment, or other circumstance that, in the investigator's judgment, may compromise the participant's ability to comply with the study procedures or protocol requirements.
  • Patients with a diagnosis of chronic pancreatitis, pancreatic neoplasms, congenital pancreatic disorders, viral infections, iron overload disorders, or a history of medication use or other medical conditions that may increase pancreatic echogenicity, thereby acting as potential confounding factors in the interpretation of the ultrasound findings.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To validate an ultrasound scoring system for the assessment of fatty pancreas by comparing it with the current gold standard, magnetic resonance imaging-based pancreatic fat quantification using proton density fat fraction (MRI-PDFF).
Tidsramme: 12 months
The diagnostic performance of the ultrasound score will be evaluated by assessing its agreement with MRI-PDFF measurements and its ability to accurately identify and grade pancreatic fat infiltration.
12 months
To identify clinical and laboratory parameters currently used in the diagnosis and follow-up of pancreatic disease that may serve as biomarkers of disease severity.
Tidsramme: 12 months
Clinical characteristics, biochemical markers, and pancreatic function parameters will be analyzed to identify variables associated with the severity of fatty pancreas and to explore their potential role as non-invasive biomarkers.
12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To evaluate the association between the degree of fatty pancreas and glucose tolerance status, as well as β-cell function.
Tidsramme: 12 months
The relationship between pancreatic fat accumulation and abnormalities in glucose metabolism will be investigated by assessing glucose tolerance and pancreatic β-cell function, with the aim of determining whether increasing pancreatic fat content is associated with impaired endocrine function and an increased risk of dysglycemia
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Efterforskere

  • Ledende efterforsker: Antonio Gasbarrini, Fondazione Policlinico Universitario Agostino Gemelli

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2020

Primær færdiggørelse (Faktiske)

23. juni 2022

Studieafslutning (Faktiske)

1. december 2023

Datoer for studieregistrering

Først indsendt

20. juli 2026

Først indsendt, der opfyldte QC-kriterier

20. juli 2026

Først opslået (Faktiske)

23. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 3507

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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