Metabotyping of Overweight and Obese Children
NCT04632511 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 232
Last updated 2024-05-16
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
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