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Identification of a Score for the Assessment of Intrapancreatic Fat

NCT07155473 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-09-04

No results posted yet for this study

Summary

The SPES clinical study aims to evaluate the relationship between pancreatic fat accumulation (pancreatic steatosis) and metabolic health. Pancreatic steatosis has been linked to conditions like type 2 diabetes (T2D) and metabolic syndrome, but the underlying mechanisms and its impact on beta-cell function remain poorly understood.

The primary goal of this study is to develop a quantitative ultrasound elastography score to measure the degree of pancreatic steatosis and explore how this relates to pancreatic beta-cell function and key factors associated with the development of type 2 diabetes and metabolic syndrome.

A secondary goal is to categorize participants into four risk classes for type 2 diabetes based on their metabolic profiles and correlate these classes with the degree of pancreatic steatosis. This may provide insights into individual risk stratification for T2D and related complications.

The study will enroll 100 participants, aged 18 to 80, attending the Endoscopic Ultrasound Unit at the Fondazione Policlinico Universitario Agostino Gemelli in Rome. Participants will undergo endoscopic ultrasound for various clinical reasons, excluding those with pancreatic tumors, cystic fibrosis, or insulin-treated diabetes. Key inclusion criteria include controlled blood glucose levels (HbA1c \< 10% or fasting glucose \< 250 mg/dL) and the ability to understand and provide informed consent.

The study is interventional but does not involve drugs or medical devices. Participants will attend a visit where medical history, physical measurements (e.g., BMI, waist circumference, blood pressure), glucose tolerance tests, and blood work will be collected. This comprehensive approach aims to better understand the metabolic implications of pancreatic steatosis and its role in type 2 diabetes development.

The study will last 24 months, including the enrollment period. Findings may contribute to improved risk stratification, prevention, and management strategies for type 2 diabetes and related conditions.

Conditions

  • Pancreatic Steatosis
  • Metabolic Syndrome X
  • Diabetes

Interventions

DIAGNOSTIC_TEST

C-peptide dosage

Measurement of C-peptide at 5 time points during a standard oral glucose tolerance test (OGTT)

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Teresa Mezza · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07155473 on ClinicalTrials.gov