Study for the Identification of a Score to Assess Intrapancreatic Fat Through Eco-Elastography and Its Correlation With Metabolic Syndrome and Insulin-Secreting Cells. (SPES)

Study for the Identification of a Quantitative Eco-Elastographic Score of Pancreatic Steatosis and Its Correlation With Beta-Cell Function and Metabolic Syndrome.

**Brief Summary of the SPES Clinical Study**

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Metabolic Syndrome X; Pancreatic Steatosis
• Intervention / Treatment: Diagnostic test: C-peptide

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Teresa Mezza; Phone Number: +393286990369; Email: teresa.mezza@unicatt.it

Study Locations

• Italy
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Recruiting
      • Gemelli University Hospistal
      • Contact: Teresa Mezza
    • Rome, Lazio, Italy, 00168
      • Recruiting
      • Gemelli University Hospital
      • Contact: Teresa Mezza; Phone Number: 0630156264; Email: teresa.mezza@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Age <18 years or >80 years
• History of diabetes treated with insulin
• HbA1c >10% or fasting glucose >250 mg/dL
• Pancreatic diseases (solid tumors/secretory NETs/cystic fibrosis; non-secretory NETs and IPMN may be included)
• Previous pancreatic surgery
• Moderate anemia (Hb <10 mg/dL)
• Severe liver failure (Child-Pugh C)
• Non-metabolic causes of NAPLD (e.g., corticosteroid therapy, antiretrovirals, gemcitabine, octreotide, history of hemochromatosis, malnutrition, HBV/HIV infections)
• Alcohol abuse (>30 g/day of ethanol)
• Pregnancy and breastfeeding
• Inability to adequately understand informed consent and study procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients Undergoing Endoscopic Ultrasound	Diagnostic test: C-peptide; Measurement of C-peptide at 5 time points during a standard oral glucose tolerance test (OGTT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Identification of a quantitative ultrasound elastography score for the degree of pancreatic steatosis	One day assessment

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation of the score with metabolic and functional parameters across the four different risk classes for type 2 diabetes.	One day assessment

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 24, 2025
• First Submitted That Met QC Criteria: January 24, 2025
• First Posted (Actual): January 30, 2025

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Nutritional and Metabolic Diseases; Metabolic Syndrome; Diabetes Mellitus
• Other Study ID Numbers: 7291

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No