Ultrasound elastography score to measure pancreatic fat
Study for the Identification of a Quantitative Eco-Elastographic Score of Pancreatic Steatosis and Its Correlation With Beta-Cell Function and Metabolic Syndrome.
We will test an ultrasound-based score that measures pancreatic fat to see if it links to insulin-producing cell function and diabetes risk in adults with or at risk for metabolic syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, Rome) |
| Trial ID | NCT07155473 on ClinicalTrials.gov |
What this trial studies
This study will develop a quantitative ultrasound elastography score to measure pancreatic steatosis and relate that score to metabolic health measures. One hundred participants aged 18–80 will be recruited at Gemelli University Hospital and undergo pancreatic ultrasound elastography, blood tests including C-peptide and glycemic markers, and metabolic profiling. Investigators will create a fat score, compute beta-cell function indices, and classify participants into four metabolic risk classes for type 2 diabetes. Correlations between the pancreatic fat score and measures of beta-cell function and diabetes risk will be analyzed.
Who should consider this trial
Good fit: Adults aged 18–80 who can give informed consent, have HbA1c under 10% (or fasting glucose under 250 mg/dL), and do not have excluded pancreatic or systemic conditions are ideal candidates.
Not a fit: People with insulin-treated diabetes, very high blood sugars (HbA1c >10% or fasting glucose >250 mg/dL), prior pancreatic surgery, severe liver failure, or active pregnancy/breastfeeding are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the score could help identify people at higher risk of type 2 diabetes so clinicians can target monitoring or preventive steps earlier.
How similar studies have performed: Previous imaging work using MRI/CT has linked pancreatic fat to metabolic risk, but quantitative ultrasound elastography for pancreatic fat scoring is relatively new and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.
Where this trial is running
Roma, Rome
- Gemelli University Hospital — Roma, Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Teresa Mezza — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Teresa Mezza
- Email: teresa.mezza@policlinicogemelli.it
- Phone: +390630155701
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.