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

Launched by CATHOLIC UNIVERSITY OF THE SACRED HEART · Jan 24, 2025

Keywords

ClinConnect Summary

The SPES clinical study is looking into how fat buildup in the pancreas, known as pancreatic steatosis, affects metabolic health, particularly in relation to type 2 diabetes and metabolic syndrome. Researchers want to create a scoring system using ultrasound technology to measure the amount of fat in the pancreas. This study aims to understand how this fat relates to the function of insulin-producing cells and to classify individuals into risk groups for type 2 diabetes based on their metabolic health.

To participate in the study, individuals must be between 18 and 80 years old, have stable blood sugar levels, and be able to provide informed consent. The study will involve around 100 participants who are already visiting a medical facility for other reasons related to their health. During the study, participants will have their medical history reviewed, physical measurements taken, and will undergo tests to assess their glucose levels. This research could help identify who is at risk of developing type 2 diabetes and improve prevention and management strategies in the future.

Gender

ALL

Eligibility criteria

• 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