Metabotyping of Overweight and Obese Children

NCT ID: NCT04632511

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-15
• Study Completion Date: 2026-12-31

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.

Detailed Description

The impetus for this research proposal stems from the ever-increasing metabolic-related health issues impacting today's children. Particularly, the high prevalence of childhood obesity accompanied by substantial progression to 'prediabetic state' at teen age and full-blown DMT2, the most prevailing endocrine disease worldwide, at early adulthood. Several risk factors for the development of overt DMT2 and crescent atherogenic processes, including unhealthy lifestyle patterns, decreased physical activity and (subsequent) obesity, that may be considered markers of metabolic abnormalities, such as insulin resistance, are already well-established in children with impaired glucose tolerance prior to time of diagnosis around early adolescence. Moreover, even in individuals with normal glucose tolerance, insulin resistance has been pointed out a major risk factor and predictor for the development of DMT2. Conversely, the micro- and macrovascular events do not readily appear until maturity, thereby predisposing obese children to the development of several long-term complications urging the quest for diagnostic, prognostic and/or predictive biomarkers for insulin resistance and related metabolic diseases. Hence, intervening in the pre-pubertal life stage becomes of paramount importance. As a pivotal component in precision medicine, and unlike routine measurements that only include a narrow set of blood chemistry analytes, metabolomics reveals a far more comprehensive metabolic signature. Taken together that DM and related comorbidities are considered metabolic diseases with a dysregulated lipid metabolism being a central factor in the pathogenesis, metabolomics (and in particular lipidomics) is of key importance in this research proposal. Furthermore, given the collision between genes, gut microbiota and environmental changes preceding the development of DM and, in addition, the excellence of stool in reflecting the metabolic interactions and outcomes thereof, an innovative rectal sampler using a medical swab with customized surface tip for optimal gut metabolome coverage will be used. REIMS significantly reduces time (< 10 s) and workload (minimal sample preparation), enhancing research output and efficiency. The aim is the early identification of children who are destined to develop obesity-related chronic diseases.

Conditions

Metabolic Disease; Obesity, Infant

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Obese group

Metabolome measurements on feces and urine.

Group Type: OTHER

MetaSAMP

Intervention Type: DEVICE

Rectal Sampler

Children with overweight, not yet obese

Metabolome measurements on feces and urine.

Group Type: OTHER

MetaSAMP

Intervention Type: DEVICE

Rectal Sampler

Normal-weight control group

Metabolome measurements on feces and urine.

Group Type: OTHER

MetaSAMP

Intervention Type: DEVICE

Rectal Sampler

Interventions

MetaSAMP

Rectal Sampler

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• prepubertal

Exclusion Criteria

• no diabetes type 1 or 2, no endocrine disease, no chronic medication

COHORT NAME: MetaBEAse

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: collaborator

Algemeen Ziekenhuis Maria Middelares

OTHER

Sponsor Role: collaborator

AZ Jan Palfijn Gent

OTHER

Sponsor Role: collaborator

AZ Sint-Lucas Gent

OTHER

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: collaborator

AZ Alma

OTHER

Sponsor Role: collaborator

AZ Sint-Jan AV

OTHER

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean De Schepper

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

Ghent University

Ghent, East-flanders, Belgium

AZ Alma

Eeklo, Oost-Vlaanderen, Belgium

AZ Sint-Elisabeth

Zottegem, Oost-Vlaanderen, Belgium

OLV Lourdes Waregem

Waregem, West-Vlaanderen, Belgium

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

Countries

Belgium

Other Identifiers

BC-06939

Identifier Type: -

Identifier Source: org_study_id