Recruiting

SPESQuantitative Eco-Elastographic Score for Pancreatic Steatosis and Its Correlation with Beta-Cell Function and Metabolic Syndrome

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Study Aim

This study aims to identify a quantitative ultrasound elastography score to measure the degree of pancreatic steatosis, and investigate its correlation with beta-cell function and metabolic syndrome in participants.

What is being tested

C-peptide

Diagnostic Test
Who is being recruted

Diabetes Mellitus+5

+ Endocrine System Diseases

+ Hyperinsulinism

From 18 to 80 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: March 2025
See protocol details

Summary

Principal SponsorCatholic University of the Sacred Heart
Study ContactTeresa Mezza
Last updated: March 21, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 17, 2025

Actual date on which the first participant was enrolled.

The SPES clinical study is designed to investigate how fat accumulation in the pancreas, known as pancreatic steatosis, affects overall metabolic health. This condition is linked to illnesses like type 2 diabetes and metabolic syndrome, but the precise effects on the pancreas's beta cells, which produce insulin, are not fully understood. The main goal is to create a new ultrasound method that accurately measures pancreatic fat and examines its connection to the functioning of beta cells and the risk of developing diabetes. The study also aims to classify participants into different risk categories for type 2 diabetes, offering potential new insights into personal risk and prevention strategies. In this study, 100 participants between the ages of 18 and 80 will visit the Endoscopic Ultrasound Unit in Rome for non-drug-related procedures. They will undergo an endoscopic ultrasound as part of their routine care, provided they don’t have specific conditions like pancreatic tumors or require insulin treatment. The study involves collecting detailed health information, including body measurements and blood tests, to assess glucose levels and metabolic health. The research will take place over 24 months, potentially improving how individuals are assessed and treated for type 2 diabetes risk and related health issues.

Official TitleStudy for the Identification of a Quantitative Eco-Elastographic Score of Pancreatic Steatosis and Its Correlation With Beta-Cell Function and Metabolic Syndrome.
Principal SponsorCatholic University of the Sacred Heart
Study ContactTeresa Mezza
Last updated: March 21, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusEndocrine System DiseasesHyperinsulinismInsulin ResistanceMetabolic DiseasesNutritional and Metabolic DiseasesMetabolic SyndromeGlucose Metabolism Disorders

Criteria

3 inclusion criteria required to participate
Age between 18 and 80 years

HbA1c < 10% or fasting glucose < 250 mg/dL

Ability to understand and provide informed consent regarding the procedures, data collection, and analysis

11 exclusion criteria prevent from participating
History of diabetes treated with insulin

Pancreatic diseases (solid tumors/secretory NETs/cystic fibrosis; non-secretory NETs and IPMN may be included)

Previous pancreatic surgery

Severe liver failure (Child-Pugh C)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Gemelli University Hospistal

Rome, ItalyOpen Gemelli University Hospistal in Google Maps
Recruiting

Gemelli University Hospital

Rome, Italy
Recruiting
2 Study Centers
SPES | Quantitative Eco-Elastographic Score for Pancreatic Steatosis and Its Correlation with Beta-Cell Function and Metabolic Syndrome | PatLynk