Study for the Identification of a Score to Assess Intrapancreatic Fat Through Eco-Elastogr
\*\*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
| Condition(s) | Pancreatic Steatosis, Metabolic Syndrome X, Diabetes Mellitus |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | 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 * In |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Catholic University of the Sacred Heart |
| Locations | Rome, Lazio, Italy; Rome, Lazio, Italy |
| Start date | 2025-03-17 |
| NCT ID | NCT06801769 |
| Official listing | https://clinicaltrials.gov/study/NCT06801769 |