Metabotyping of Overweight and Obese Children

NCT04632511 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2024-05-16

No results posted yet for this study

Summary

Today's children are increasingly facing metabolic-related health issues, among which the worldwide prevalence of overweight and obesity is rising at an alarming pace. Childhood obesity is associated with the early onset of chronic diseases including an emergence of prediabetes and diabetes mellitus type 2. The decline of insulin sensitivity already years before puberty, exposes children to long- term complications prior the appearance of clinical symptoms and time of diagnosis. The shortened life expectancy and large economic burden imposed underlines the need for the identification of metabotypes at risk at an early stage. One's genetics, microbial gut composition and every aspect of the environment in which children are raised have been implicated in diet-related obesity rendering metabolomics a very powerful tool towards precision medicine. Yet, the excellence of stool in reflecting the intertwining thereof is completely unexplored for pediatric purposes, whereas blood sampling causing pain and stress for child and parent only captures a narrow fraction of the metabolome. As such, rectal sampling using a customised medical swab for optimal gut metabolome coverage is envisioned. Ambient laser desorption ionisation will be hyphenated to high-resolution mass spectrometry-based metabolomics to provide a framework for elucidating predictive and/or prognostic biomarkers for ever-increasing pediatric metabolic diseases such as obesity and (pre)diabetes.

Conditions

  • Metabolic Disease
  • Obesity, Infant

Interventions

DEVICE

MetaSAMP

Rectal Sampler

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER
  • Universitair Ziekenhuis Brussel

    collaborator OTHER
  • Algemeen Ziekenhuis Maria Middelares

    collaborator OTHER
  • AZ Jan Palfijn Gent

    collaborator OTHER
  • AZ Sint-Lucas Gent

    collaborator OTHER
  • University Hospital, Antwerp

    collaborator OTHER
  • AZ Alma

    collaborator OTHER
  • AZ Sint-Jan AV

    collaborator OTHER
  • University Ghent

    lead OTHER

Principal Investigators

  • Jean De Schepper · University Ghent

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-15
Primary Completion
2022-03-31
Completion
2026-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04632511 on ClinicalTrials.gov