Ireland
--:--IST
Active, not recruiting Not applicable

Metabotyping of Overweight and Obese Children

NCT04632511 · tracked via the Priya Life Science Belgium tracker
Phase
Not applicable
Started
2021-02-15
Last updated
2024-05-16

Condition(s) studied

Metabolic DiseaseObesity, Infant

Investigational drug(s) / intervention(s)

MetaSAMP

MetaSAMP: Rectal Sampler

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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
Accepted
Inclusion Criteria: * prepubertal Exclusion Criteria: * no diabetes type 1 or 2, no endocrine disease, no chronic medication COHORT NAME: MetaBEAse

Primary outcome measure(s)

  • rectal MetaSAMP — 2 years
    Fecal metabolomics vs MetaSAMP (congruence)

Trial sites (10)

FacilityCityRegionStatus
Ghent University Ghent East-flanders
AZ Alma Eeklo Oost-Vlaanderen
AZ Sint-Elisabeth Zottegem Oost-Vlaanderen
OLV Lourdes Waregem Waregem West-Vlaanderen
UZA Antwerp Belgium
AZ Sint-Jan Brugge Bruges Belgium
General Hospital Jan-Palfijn Ghent Belgium
General Hospital Sint-Lucas Ghent Belgium
University Hospital Brussels Jette Belgium
University Hospital Leuven Leuven Belgium
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04632511 on ClinicalTrials.gov ↗ ← All trials in Belgium