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

NCT ID: NCT06801769

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients Undergoing Endoscopic Ultrasound

Group Type: EXPERIMENTAL

C-peptide

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

C-peptide

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Teresa Mezza

M.D, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Teresa Mezza

Role: CONTACT

teresa.mezza@unicatt.it

+393286990369

Other Identifiers

7291

Identifier Type: -

Identifier Source: org_study_id