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Metabotyping of Overweight and Obese Children (RecSAMP)

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ClinicalTrials.gov Identifier: NCT04632511
Recruitment Status : Recruiting
First Posted : November 17, 2020
Last Update Posted : March 5, 2021
Sponsor:
Collaborators:
Universitaire Ziekenhuizen Leuven
Universitair Ziekenhuis Brussel
Algemeen Ziekenhuis Maria Middelares
AZ Jan Palfijn Gent
AZ Sint-Lucas Gent
Information provided by (Responsible Party):
University Ghent

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metabolic Disease Obesity, Infant Device: RECSAMP Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Obese children, children with overweight and normal-weight children
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Metabotyping of Overweight and Obese Children Towards Early Detection of Insulin Resistance and Low-grade Inflammation by Means of a Rectal Sampler
Actual Study Start Date : February 15, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Obese group
Metabolome measurements on feces and urine.
 Device: RECSAMP
Rectal Sampler
Children with overweight, not yet obese
Metabolome measurements on feces and urine.
 Device: RECSAMP
Rectal Sampler
Normal-weight control group
Metabolome measurements on feces and urine.
 Device: RECSAMP
Rectal Sampler


Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic biomarkers [ Time Frame: 1 year ]

    The elucidation of candidate biomarkers in the early diagnosis of insulin resistance.

    The study aims to initially discover differences in metabolic fingerprints of normal-weight versus children with extreme overweight/obesity.

    The metabolic fingerprints (obtained through state-of-the-art metabolomics technology performed on faecal and urine samples as well as ambient mass spectrometry performed on the rectal swabs) will be correlated to diverse parameters currently addressed in the diagnosis of obesity. Such parameters include BMI z-score, sleeping pattern, anthropometric measurements (waist circumference, standing height, etc.) and clinical blood parameters (standard routine ones like cholesterol, uric acid, ALT, etc.).

    This will enable to include the aforementioned diverse parameters as plausible covariates (e.g. sex, age, ethnicity, sleeping patterns, etc.) in obtaining true clusters/categories of different metabolic profiles according to underlying metabolic abnormalities.



Secondary Outcome Measures :
  1. Predictive and prognostic biomarkers [ Time Frame: 3 years ]

    The elucidation of predictive and prognostic biomarkers of obesity- and insulin resistance-related metabolic diseases like diabetes type 2.

    The metabolic fingerprints obtained will be categorised, based on the aforementioned parameters, during the follow-up period in order to retrieve markers of predictive and/or prognostic value with respect to the development and/or progression of obesity-related comorbidities.

    In this regard, centralised serum samples* will be analysed at UZ Brussel at start, after 1 and 2 years of follow-up, only for the patient group (glucose, insulin, CRP, SHBG, adiponectin, leptine and free fatty acids) to correlate the metabolic profiles to metabolic abnormalities (based on those blood measurements) like dyslipidemia, low-grade inflammation, etc.

    *Those measurements impart 1 extra serum sample taken by the pediatricians during routine practice (so the patients already do need to come in fasting for blood sampling on those days of consultation).



Eligibility Criteria
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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • prepubertal

Exclusion Criteria:

  • no diabetes type 1 or 2, no endocrine disease, no chronic medication
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04632511


Contacts
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Contact: Jean De Schepper 09 332 27 60 jean.deschepper@uzbrussel.be

Locations
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Belgium
Ghent University Recruiting
Ghent, East-flanders, Belgium, 9000
Contact: Lynn Vanhaecke, Prof.    0495590750    Lynn.Vanhaecke@UGent.be   
Sylvia Depoorter Recruiting
Bruges, Belgium, 8000
Contact: Sylvia Depoorter    0478248178    sylviaa.depoorter@azsintjan.be   
General Hospital Jan-Palfijn Recruiting
Ghent, Belgium, 9000
Contact: Nele Baeck    09 224 71 11    nele.baeck@azjanpalfijn.be   
General Hospital Maria-Middelares Recruiting
Ghent, Belgium, 9000
Contact: Jelle Degraeuwe    09 246 46 46    jelle.degraeuwe@azmmsj.be   
General Hospital Sint-Lucas Recruiting
Ghent, Belgium, 9000
Contact: Sofie Deman    09 224 54 13    sofie.deman@azstlucas.be   
Principal Investigator: Sofie Deman         
University Hospital Brussels Recruiting
Jette, Belgium, 1090
Contact: Inge Gies    023060223    inge.gies@uzbrussel.be   
University Hospital Leuven Recruiting
Leuven, Belgium, 3000
Contact: Kristina Casteels    016343991    kristina.casteels@uzleuven.be   
Sponsors and Collaborators
University Ghent
Universitaire Ziekenhuizen Leuven
Universitair Ziekenhuis Brussel
Algemeen Ziekenhuis Maria Middelares
AZ Jan Palfijn Gent
AZ Sint-Lucas Gent
Investigators
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Principal Investigator: Jean De Schepper University Ghent
More Information
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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT04632511    
Other Study ID Numbers: BC-06939
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Ghent:
metabolomics
mass spectrometry
Additional relevant MeSH terms:
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Metabolic Diseases
Pediatric Obesity
Overweight
Body Weight
 Obesity
Overnutrition
Nutrition Disorders