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

NCT06801769 | Recruiting

• 1 other identifier: 7291
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

\*\*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.

Conditions

Pancreatic Steatosis; Metabolic Syndrome X; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Identification of a quantitative ultrasound elastography score for the degree of pancreatic steatosis

  One day assessment

Secondary Outcomes (1)

• Correlation of the score with metabolic and functional parameters across the four different risk classes for type 2 diabetes.

  One day assessment

Study Arms (1)

Patients Undergoing Endoscopic Ultrasound

EXPERIMENTAL

Diagnostic Test: C-peptide

Interventions

C-peptide DIAGNOSTIC_TEST

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

Patients Undergoing Endoscopic Ultrasound

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (2)

Gemelli University Hospistal

Rome, Lazio, 00168, Italy

RECRUITING

Gemelli University Hospital

Rome, Lazio, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Teresa Mezza

CONTACT

+393286990369; teresa.mezza@unicatt.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistent Professor

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: January 30, 2025
• Study Start: March 17, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

IT (2)