Actively Recruiting
Identification of a Score for the Assessment of Intrapancreatic Fat
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-09-04
100
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Identification of a Score for the Assessment of Intrapancreatic Fat
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- HbA1c less than 10% or fasting glucose less than 250 mg/dL
- Ability to understand and provide informed consent for study procedures and data use
You will not qualify if you...
- Age less than 18 or greater than 80 years
- Diabetes treated with insulin
- HbA1c greater than 10% or fasting glucose greater than 250 mg/dL
- Pancreatic diseases such as solid tumors, secretory neuroendocrine tumors, cystic fibrosis; non-secretory neuroendocrine tumors and IPMN may be included
- Previous pancreatic surgery
- Moderate anemia (hemoglobin less than 10 mg/dL)
- Severe liver failure (Child-Pugh C)
- Non-metabolic causes of non-alcoholic fatty liver disease such as corticosteroid therapy, antiretrovirals, gemcitabine, octreotide, history of hemochromatosis, malnutrition, HBV or HIV infections
- Alcohol abuse (more than 30 grams per day of ethanol)
- Pregnancy and breastfeeding
- Inability to understand informed consent and study procedures
AI-Screening
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Trial Site Locations
Total: 1 location
1
Gemelli University Hospital
Roma, Rome, Italy, 00168
Actively Recruiting
Research Team
T
Teresa Mezza
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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