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

Plain-language guide to NCT06801769: not phased interventional trial of C-Peptide, 100 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT06801769
Phase: not phased
Status: recruiting participants
Start: 2025-03-17
Completion (planned or actual): 2026-12
Participants: 100 (estimated)
Design: na, open label (everyone knows who gets what), diagnostic
Conditions studied: Pancreatic Steatosis; Metabolic Syndrome X; Diabetes Mellitus
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test C-Peptide.

\*\*Brief Summary of the SPES Clinical Study\*\* The SPES clinical study aims to evaluate the relationship between pancreatic fat accumulation (pancreatic steatosis) and metabolic health.

Pancreatic steatosis has been linked to conditions like type 2 diabetes (T2D) and metabolic syndrome, but the underlying mechanisms and its impact on beta-cell function remain poorly understood.

It had 1 arm (groups): Patients Undergoing Endoscopic Ultrasound (experimental).

The registry classes the interventions as diagnostic test.

Who Took Part

100 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age between 18 and 80 years. Ability to understand and provide informed consent regarding the procedures, data collection, and analysis.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: age \<18 years or \>80 years; history of diabetes treated with insulin; pancreatic diseases (solid tumors/secretory nets/cystic fibrosis; non-secretory nets and ipmn may be included).

How the Study Was Run

Design: single-group and open-label.

Being open-label, the C-Peptide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2025-03-17 with completion listed for 2026-12.

It ran at 2 sites in Italy (2).

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: Identification of a quantitative ultrasound elastography score for the degree of pancreatic steatosis (time frame: One day assessment).

It also tracked 1 secondary outcome, for example Correlation of the score with metabolic and functional parameters across the four different risk classes for type 2 diabetes.

What This Means in Plain Language

Put simply, this is a not phased trial of C-Peptide in 100 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the C-Peptide compound page, all human trials.

Our Notes on the Compound

C-Peptide: The 31-amino-acid fragment cut from proinsulin when insulin is made; it has been given as an investigational treatment in a few trials.

C-Peptide in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.