Metabotyping of Overweight and Obese Children (RecSAMP)

May 8, 2023 updated by: University Ghent

Metabotyping of Overweight and Obese Children Towards Early Detection of Insulin Resistance and Low-grade Inflammation by Means of a Rectal Sampler

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

232

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Antwerp, Belgium
        • UZA
      • Bruges, Belgium, 8000
        • AZ Sint-Jan Brugge
      • Ghent, Belgium, 9000
        • General Hospital Jan-Palfijn
      • Ghent, Belgium, 9000
        • General Hospital Sint-Lucas
      • Jette, Belgium, 1090
        • University Hospital Brussels
      • Leuven, Belgium, 3000
        • University Hospital Leuven
    • East-flanders
      • Ghent, East-flanders, Belgium, 9000
        • Ghent University
    • Oost-Vlaanderen
      • Eeklo, Oost-Vlaanderen, Belgium, 9900
        • AZ Alma
      • Zottegem, Oost-Vlaanderen, Belgium, 9620
        • AZ Sint-Elisabeth
    • West-Vlaanderen
      • Waregem, West-Vlaanderen, Belgium
        • OLV Lourdes Waregem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • prepubertal

Exclusion Criteria:

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

COHORT NAME: MetaBEAse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Obese group
Metabolome measurements on feces and urine.
Rectal Sampler
Other: Children with overweight, not yet obese
Metabolome measurements on feces and urine.
Rectal Sampler
Other: Normal-weight control group
Metabolome measurements on feces and urine.
Rectal Sampler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rectal MetaSAMP
Time Frame: 2 years
Fecal metabolomics vs MetaSAMP (congruence)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolome markers
Time Frame: 4 years
predictive/prognostic value in scope of risk assessment
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2021

Primary Completion (Actual)

March 31, 2022

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

November 9, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 17, 2020

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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