Ultrasound elastography score for pancreas fat and its link to metabolic health
Official title: Study for the Identification of a Quantitative Eco-Elastographic Score of Pancreatic Steatosis and Its Correlation With Beta-Cell Function and Metabolic Syndrome.
Run by Catholic University of the Sacred Heart · NCT06801769 · Data updated 2026-11-12
The team will see if an ultrasound elastography score of pancreatic fat relates to beta-cell function and diabetes risk in adults with metabolic syndrome or diabetes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Catholic University of the Sacred Heart Academic / other |
| Locations | 2 sites (Rome, Lazio and 1 other locations) |
| Status | Recruiting |
| Started | March 17, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | March 20, 2026 |
| Trial ID | NCT06801769 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 with pancreatic steatosis, metabolic syndrome, or diabetes who have HbA1c <10% (or fasting glucose <250 mg/dL), are not treated with insulin, and can give informed consent are ideal candidates.
✕Probably not a fit
People with insulin-treated diabetes, HbA1c >10% or fasting glucose >250 mg/dL, prior pancreatic surgery, excluded pancreatic diseases, pregnancy, or other listed exclusion conditions are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study will enroll about 100 adult participants with a range of metabolic profiles and use ultrasound elastography to generate a quantitative score of intrapancreatic fat. Participants will have blood tests including C-peptide and glucose metrics, clinical assessments for metabolic syndrome, and imaging to correlate the fat score with beta-cell function. Researchers will classify participants into four diabetes-risk classes based on metabolic profiles and analyze how the elastography score varies across these groups. The goal is to create a reproducible imaging biomarker that could help stratify risk for type 2 diabetes and guide future research and care decisions.
Why it matters
Potential benefit: If successful, this approach could give clinicians a noninvasive imaging biomarker to identify people at higher risk of diabetes and to monitor pancreatic fat over time.
How similar studies have gone: Some prior imaging studies have linked pancreatic fat to metabolic disease, but creating and validating a quantitative ultrasound elastography score correlated with beta-cell function is relatively novel and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Gemelli University Hospistal
Rome, Lazio, Italy Recruiting -
Gemelli University Hospital
Rome, Lazio, Italy Recruiting
Study contacts
- Study coordinator: Teresa Mezza
- Email: teresa.mezza@unicatt.it
- Phone: +393286990369
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.