Metabolic DiseaseRecSAMPNCT04632511
Metabotyping of Overweight and Obese Children
A study testing MetaSAMP in people with Metabolic Disease and Obesity, Infant, run by University Ghent at 10 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease, Obesity, Infant
- What is being tested?
- MetaSAMP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 10 sitesBelgium
- Study dates
- 15 Feb 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- prepubertal
Who cannot join
- no diabetes type 1 or 2, no endocrine disease, no chronic medication
- COHORT NAME: MetaBEAse
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Belgium10 sites
UZA
Antwerp
AZ Sint-Jan Brugge
Bruges, 8000
AZ Alma
Eeklo, Oost-Vlaanderen, 9900
Ghent University
Ghent, East-flanders, 9000
General Hospital Jan-Palfijn
Ghent, 9000
General Hospital Sint-Lucas
Ghent, 9000
University Hospital Brussels
Jette, 1090
University Hospital Leuven
Leuven, 3000
OLV Lourdes Waregem
Waregem, West-Vlaanderen
AZ Sint-Elisabeth
Zottegem, Oost-Vlaanderen, 9620
About this study
Official title: 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.
Read the 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
- Being tested
- MetaSAMP
- Keywords
- metabolomics, mass spectrometry
- Medical subject headings
- Metabolic Diseases, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetaSAMPDevice
Rectal Sampler
| Study group | Role | What they receive |
|---|---|---|
| Obese group | Other | Metabolome measurements on feces and urine. Receives: Device: MetaSAMP |
| Children with overweight, not yet obese | Other | Metabolome measurements on feces and urine. Receives: Device: MetaSAMP |
| Normal-weight control group | Other | Metabolome measurements on feces and urine. Receives: Device: MetaSAMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
rectal MetaSAMP
Fecal metabolomics vs MetaSAMP (congruence)
Measured: 2 years
Secondary outcomes (1)
Metabolome markers
predictive/prognostic value in scope of risk assessment
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start15 Feb 2021
- Primary completion31 Mar 2022
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Children with overweight and obesity and normal-weight children
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Universitair Ziekenhuis Brussel, Algemeen Ziekenhuis Maria Middelares, AZ Jan Palfijn Gent, AZ Sint-Lucas Gent, University Hospital, Antwerp, AZ Alma, AZ Sint-Jan AV
- Responsible party
- Sponsor
- Investigators
- Jean De Schepper, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632511
- Sponsor's protocol ID
- BC-06939
- Acronym
- RecSAMP
- Status last verified
- May 2024
- First submitted
- 9 Nov 2020
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabotyping of Overweight and Obese Children Towards Early Detection of Insulin Resistance and Low-grade Inflammation by Means of a Rectal Sampler
- ClinicalTrials.gov ID
- NCT04632511
- Acronym / sponsor ID
- RecSAMP / BC-06939
- Conditions
- Metabolic Disease, Obesity, Infant
- Keywords
- metabolomics, mass spectrometry
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 232 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Universitair Ziekenhuis Brussel, Algemeen Ziekenhuis Maria Middelares, AZ Jan Palfijn Gent, AZ Sint-Lucas Gent, University Hospital, Antwerp, AZ Alma, AZ Sint-Jan AV
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Children with overweight and obesity and normal-weight children
| Arm | Type | Receives |
|---|---|---|
| Obese group | Other | Device: MetaSAMPMetabolome measurements on feces and urine. |
| Children with overweight, not yet obese | Other | Device: MetaSAMPMetabolome measurements on feces and urine. |
| Normal-weight control group | Other | Device: MetaSAMPMetabolome measurements on feces and urine. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- prepubertal
Key exclusion criteria (2 listed)
- no diabetes type 1 or 2, no endocrine disease, no chronic medication
- COHORT NAME: MetaBEAse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetaSAMPRectal Sampler | Device | Children with overweight, not yet obese, Normal-weight control group, Obese group |
Primary outcome
rectal MetaSAMP
Time frame: 2 years
Fecal metabolomics vs MetaSAMP (congruence)
1 secondary outcome
Metabolome markers
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean De Schepper principal investigator
University Ghent
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MetaSAMP in people with Metabolic Disease and Obesity, Infant, run by University Ghent at 10 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rectal MetaSAMP (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.