Clinical trial

Metabotyping of Overweight and Obese Children

Active, not recruiting ยท Not applicable ยท 1 countries ยท Registry ID NCT04632511

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age6 Years to 12 Years
SexAll
Healthy volunteersAccepted
ConditionMetabolic Disease, Obesity, Infant

Full registry criteria

Inclusion Criteria: * prepubertal Exclusion Criteria: * no diabetes type 1 or 2, no endocrine disease, no chronic medication COHORT NAME: MetaBEAse

Treatments and study arms

MetaSAMP

Device

Rectal Sampler

Primary outcomes

rectal MetaSAMP2 years

Fecal metabolomics vs MetaSAMP (congruence)

Study locations

10 locations were listed when this page was built. The first 40 are shown.

UZA๐Ÿ‡ง๐Ÿ‡ช Antwerp, Belgium
AZ Sint-Jan Brugge๐Ÿ‡ง๐Ÿ‡ช Bruges, Belgium
AZ Alma๐Ÿ‡ง๐Ÿ‡ช Eeklo, Oost-Vlaanderen, Belgium
General Hospital Jan-Palfijn๐Ÿ‡ง๐Ÿ‡ช Ghent, Belgium
General Hospital Sint-Lucas๐Ÿ‡ง๐Ÿ‡ช Ghent, Belgium
Ghent University๐Ÿ‡ง๐Ÿ‡ช Ghent, East-flanders, Belgium
University Hospital Brussels๐Ÿ‡ง๐Ÿ‡ช Jette, Belgium
University Hospital Leuven๐Ÿ‡ง๐Ÿ‡ช Leuven, Belgium
OLV Lourdes Waregem๐Ÿ‡ง๐Ÿ‡ช Waregem, West-Vlaanderen, Belgium
AZ Sint-Elisabeth๐Ÿ‡ง๐Ÿ‡ช Zottegem, Oost-Vlaanderen, Belgium