Ultrasound elastography score for pancreas fat and its link to metabolic health
Study for the Identification of a Quantitative Eco-Elastographic Score of Pancreatic Steatosis and Its Correlation With Beta-Cell Function and Metabolic Syndrome.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Catholic University of the Sacred Heart Academic / other |
| Locations | 2 sites (Rome, Lazio and 1 other locations) |
| Trial ID | NCT06801769 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rome, Lazio and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.