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Study for the Identification of a Score to Assess Intrapancreatic Fat Through Eco-Elastography and Its Correlation With Metabolic Syndrome and Insulin-Secreting Cells.

RecruitingNAAges 18 Years - 80 YearsAllCatholic University of the Sacred Heart
NCT06801769 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

\*\*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 i

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📋 Eligibility rules (as published)
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
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What it tests

  • C-peptide
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Where

2 sites
Gemelli University Hospistal
Rome, Italy
Gemelli University Hospital
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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