NCT05761210

Brief Summary

With the project proposal we aim to identify serum markers for the characterization of steatosis in subjects affected by essential obesity at a young age. In this case the markers could be useful not only for the development of new diagnostic scores, or for combining them with diagnostic imaging technologies, but also for understanding the metabolic alterations according to the patient's gender, extremely important data in this disease to which only recently has biomedical research started.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

October 2, 2024

Status Verified

October 1, 2024

Enrollment Period

2.5 years

First QC Date

February 27, 2023

Last Update Submit

October 1, 2024

Conditions

Obesity

Keywords

ObesityProteomeSteatosisBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Identification of serum markers (proteomic analysis) for the characterization of steatosis in young subjects with essential obesity

    Identification of serum markers (proteomic analysis)for the characterization of steatosis in young subjects with essential obesity

    Baseline

Secondary Outcomes (1)

  • Relationships between proteoma and body composition (evaluated throughout bioimpedentiometry)

    Baseline

Study Arms (2)

cases; subjects with steatosis

Diagnostic Test: Blood sample collection

controls; subjects without steatosis

Diagnostic Test: Blood sample collection

Interventions

Blood sample collectionDIAGNOSTIC_TEST

Blood sample collection

cases; subjects with steatosiscontrols; subjects without steatosis

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Obese adolescents (BMI SDS \> 2) with or without steatosis

You may qualify if:

  • obesity (BMI SDS \> 2)
  • age range: 13-18

You may not qualify if:

  • \- age \< 13 years and \> 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano IRCCS, Site Piancavallo

Oggebbio, Verbania, 28824, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum/plasma samples

MeSH Terms

Conditions

ObesityFatty Liver

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2023

First Posted

March 9, 2023

Study Start

April 19, 2022

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

October 2, 2024

Record last verified: 2024-10

Locations

IT(1)