Identification of a Score for the Assessment of Intrapancreatic Fat
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: C-peptide dosage.
- Who it may be relevant to
- Registry conditions: Pancreatic Steatosis, Metabolic Syndrome X, Diabetes. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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.
Interventions
- Diagnostic test C-peptide dosage
Measurement of C-peptide at 5 time points during a standard oral glucose tolerance test (OGTT)
Primary outcome measures
- Degree of pancreatic steatosis [Time frame: 1 day]
Secondary outcome measures (1)
- Evaluation of metabolic and functional parameters [Time frame: 1 day]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Italy · 1 center
- Gemelli University Hospital — Roma
Identifiers
NCT: NCT07155473 · 7291