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NCT Number: NCT07155473

Identification of a Score for the Assessment of Intrapancreatic Fat

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.

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Key information

Conditions

Pancreatic Steatosis Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Metabolic Syndrome X Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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.

Treatment and study plan

C-peptide dosage

Diagnostic Test

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

Primary outcomes

  1. Degree of pancreatic steatosis

    Time frame: 1 day

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

Secondary outcomes

  1. Evaluation of metabolic and functional parameters

    Time frame: 1 day

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

Study contacts

Contact information is provided by the study sponsor or research team.

Teresa Mezza

CONTACT

[email protected]

+390630155701

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: SPES

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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