Actively Recruiting
Study for the Identification of a Quantitative Eco-Elastographic Score of Pancreatic Steatosis and Its Correlation With Beta-Cell Function and Metabolic Syndrome
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-09-04
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the connection between pancreatic fat buildup (pancreatic steatosis) and metabolic health, focusing on conditions like type 2 diabetes and metabolic syndrome. The study aims to develop an ultrasound elastography score to measure pancreatic steatosis and examine its relationship with beta-cell function and factors linked to type 2 diabetes development. Additionally, participants will be classified into risk groups for type 2 diabetes based on their metabolic profiles and pancreatic fat levels. The study involves 100 participants aged 18 to 80 who are undergoing endoscopic ultrasound for clinical reasons unrelated to pancreatic tumors, cystic fibrosis, or insulin-treated diabetes. During the study visit, medical history and physical measurements such as BMI, waist circumference, and blood pressure will be collected. Participants will also undergo glucose tolerance testing and blood work, including C-peptide measurement at five time points during a standard oral glucose tolerance test. Participants will be involved for a total of 24 months, including enrollment. Assessments include a single day of measuring the degree of pancreatic steatosis and evaluating metabolic and functional parameters. The study does not involve drugs or devices but seeks to better understand how pancreatic fat relates to metabolic health and type 2 diabetes risk, potentially improving future prevention and management strategies.
CONDITIONS
Brief 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 regarding the procedures, data collection, and analysis
You will not qualify if you...
- Age under 18 years or over 80 years
- History of 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, or cystic fibrosis
- Previous pancreatic surgery
- Moderate anemia with 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, or HBV/HIV infections
- Alcohol abuse exceeding 30 grams of ethanol per day
- Pregnancy and breastfeeding
- Inability to adequately understand informed consent and study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo endoscopic ultrasound and C-peptide measurements during an oral glucose tolerance test to assess intrapancreatic fat and beta-cell function.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Gemelli University Hospital
Roma, Rome, Italy, 00168
Actively Recruiting
Research Team
T
Teresa Mezza
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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