Fact CheckerSign in

NCT04632511Active, not recruiting

Metabotyping of Overweight and Obese Children

Metabotyping of Overweight and Obese Children Towards Early Detection of Insulin Resistance and Low-grade Inflammation by Means of a Rectal Sampler

Source: ClinicalTrials.gov · Last updated 16 May 2024

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
232 (actual)
First submitted
9 Nov 2020
Start date
15 Feb 2021
Primary completion date
31 Mar 2022
Lead sponsor
University Ghent
Diseases
Obesity
NCT number
NCT04632511

What you commit to

  • Study type: Interventional
  • Participants enrolled: 232
  • From 15 Feb 2021 to the primary completion date, 31 Mar 2022
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • no diabetes type 1 or 2, no endocrine disease, no chronic medication
    • COHORT NAME: MetaBEAse

Who the study is looking for

  • prepubertal

Age in the registry: 6 years to 12 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UZA
Coordinator of this site? Confirm its status
AntwerpBelgiumUnknown status
Az Sint Jan Brugge
Coordinator of this site? Confirm its status
BrugesBelgiumUnknown status
AZ Alma
Coordinator of this site? Confirm its status
EekloBelgiumUnknown status
General Hospital Sint-Lucas
Coordinator of this site? Confirm its status
GhentBelgiumUnknown status
General Hospital Jan-Palfijn
Coordinator of this site? Confirm its status
GhentBelgiumUnknown status
Ghent University
Coordinator of this site? Confirm its status
GhentBelgiumUnknown status
University Hospital Brussels
Coordinator of this site? Confirm its status
JetteBelgiumUnknown status
University Hospital Leuven
Coordinator of this site? Confirm its status
LeuvenBelgiumUnknown status
OLV Lourdes Waregem
Coordinator of this site? Confirm its status
WaregemBelgiumUnknown status
AZ Sint-Elisabeth
Coordinator of this site? Confirm its status
ZottegemBelgiumUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.