Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04632511 |
| Other study ID # |
BC-06939 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 15, 2021 |
| Est. completion date |
December 31, 2026 |
Study information
| Verified date |
May 2024 |
| Source |
University Ghent |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
