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Completed
NCT07722689
Validation of an Ultrasound Score for Fatty Pancreas
Conditions: Fatty Pancreas
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Enrollment: 36
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Location: Fondazione Policlinico Universitario Agostino Gemelli Roma
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.
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 \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.
Source: ClinicalTrials.gov (NCT07722689). StuddyBuddy aggregates publicly available trial information.