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Identification of a Score for the Assessment of Intrapancreatic Fat

Plain-language guide to NCT07155473: not phased interventional trial of C-Peptide, 100 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07155473
Phase
not phased
Status
recruiting participants
Start
2025-03-01
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
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested C-Peptide.

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 Underwent Endoscopic Ultrasound (experimental).

Patients in this group underwent endoscopic ultrasound for their own clinical reasons.

The registry classes the interventions as diagnostic test.

Who Took Part

The registry lists 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.

The full record lists 0 inclusion and 14 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.

Everyone knew when C-Peptide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2025-03-01 with completion listed for 2026-12.

It ran at 1 site in Italy.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Degree of pancreatic steatosis (time frame: 1 day).

It also tracked 1 secondary outcome, for example Evaluation of metabolic and functional parameters.

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.

Related Pages

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.