Clinical trial NCT06801769: Study for the Identification of a Score to Assess Intrapancreatic Fat Through Eco-Elastography and Its Correlation with Metabolic Syndrome and Insulin-Secreting Cells.
Official title: Study for the Identification of a Quantitative Eco-Elastographic Score of Pancreatic Steatosis and Its Correlation with Beta-Cell Function and Metabolic Syndrome.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreatic Steatosis
Metabolic Syndrome X
Diabetes Mellitus
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Identification of a quantitative ultrasound elastography score for the degree of pancreatic steatosis
timeFrame: One day assessment
Secondary outcomes:
measure: Correlation of the score with metabolic and functional parameters across the four different risk classes for type 2 diabetes.
timeFrame: One day assessment
Other outcomes:
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