SPESQuantitative Eco-Elastographic Score for Pancreatic Steatosis and Its Correlation with Beta-Cell Function and Metabolic Syndrome
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.
C-peptide
Diabetes Mellitus+5
+ Endocrine System Diseases
+ Hyperinsulinism
Diagnostic Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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
Gemelli University Hospital
Rome, Italy