Status:
RECRUITING
Identification of a Score for the Assessment of Intrapancreatic Fat
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Pancreatic Steatosis
Metabolic Syndrome X
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07155473
Start Date
March 1 2025
End Date
December 1 2026
Last Update
September 4 2025
Active Locations (1)
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1
Gemelli University Hospital
Roma, Rome, Italy, 00168