Fatty PancreasNCT07722689
Validation of an Ultrasound Score for Fatty Pancreas
An observational study of Fatty Pancreas, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fatty Pancreas
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2020to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Fatty Pancreas
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
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.
Measured: 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.
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.
Measured: 12 months
Secondary outcomes (1)
To evaluate the association between the degree of fatty pancreas and glucose tolerance status, as well as β-cell function.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Oct 2020
- Primary completion23 Jun 2022
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty PancreasStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Gasbarrini, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722689
- Sponsor's protocol ID
- 3507
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study for the Validation of an Ultrasound Scoring System for the Assessment of Fatty Pancreas
- ClinicalTrials.gov ID
- NCT07722689
- Acronym / sponsor ID
- 3507
- Conditions
- Fatty Pancreas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Time frame: 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.
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.
Time frame: 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.
1 secondary outcome
To evaluate the association between the degree of fatty pancreas and glucose tolerance status, as well as β-cell function.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Gasbarrini principal investigator
Fondazione Policlinico Universitario Agostino Gemelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatty Pancreas, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.