NCT04632511

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Feb 2021Dec 2026

First Submitted

Initial submission to the registry

November 9, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

November 9, 2020

Last Update Submit

May 14, 2024

Conditions

Metabolic DiseaseObesity, Infant

Keywords

metabolomicsmass spectrometry

Outcome Measures

Primary Outcomes (1)

  • rectal MetaSAMP

    Fecal metabolomics vs MetaSAMP (congruence)

    2 years

Secondary Outcomes (1)

  • Metabolome markers

    4 years

Study Arms (3)

Obese group

OTHER

Metabolome measurements on feces and urine.

Device: MetaSAMP

Children with overweight, not yet obese

OTHER

Metabolome measurements on feces and urine.

Device: MetaSAMP

Normal-weight control group

OTHER

Metabolome measurements on feces and urine.

Device: MetaSAMP

Interventions

MetaSAMPDEVICE

Rectal Sampler

Children with overweight, not yet obeseNormal-weight control groupObese group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • prepubertal

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Ghent University

Ghent, East-flanders, 9000, Belgium

Location

AZ Alma

Eeklo, Oost-Vlaanderen, 9900, Belgium

Location

AZ Sint-Elisabeth

Zottegem, Oost-Vlaanderen, 9620, Belgium

Location

OLV Lourdes Waregem

Waregem, West-Vlaanderen, Belgium

Location

UZA

Antwerp, Belgium

Location

AZ Sint-Jan Brugge

Bruges, 8000, Belgium

Location

General Hospital Jan-Palfijn

Ghent, 9000, Belgium

Location

General Hospital Sint-Lucas

Ghent, 9000, Belgium

Location

University Hospital Brussels

Jette, 1090, Belgium

Location

University Hospital Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Metabolic DiseasesPediatric Obesity

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesObesityOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jean De Schepper

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Children with overweight and obesity and normal-weight children
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 17, 2020

Study Start

February 15, 2021

Primary Completion

March 31, 2022

Study Completion (Estimated)

December 31, 2026

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(10)