Validation of an Ultrasound Score for Fatty Pancreas | NCT07722689

NCT07722689

Overview

NCT ID: NCT07722689
Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER
Official Title: Prospective Observational Study for the Validation of an Ultrasound Scoring System for the Assessment of Fatty Pancreas
Brief Summary: 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.
Conditions: Fatty Pancreas
Interventions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.