Childhood Obesity Risk Markers (MARIOBE)
ConditionObesity & Overweight
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-4
SponsorUniversity Hospital, Clermont-Ferrand
About this trial
Metabolic diseases, including childhood obesity, represent a major public health challenge. Studies in mice have identified transcriptomic markers in adipose tissue capable of predicting a predisposition to obesity prior to any weight gain. The MARIOBE project aims to translate this approach to young children (≤ 4 years old) in order to identify individual vulnerability to obesity at an early stage.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Child scheduled for surgery allowing for the harvesting of adipose tissue.
Disqualifiers
Child whose holders of parental authority are protected by law
Trial design
Design model
Single group
Treatments tested in this trial
early transcriptomic markers
Other interventionduring a scheduled surgery before the age of 4 years, collection of a blood sample (2.5 mL in a PAXgene tube) and two adipose tissue fragments, each measuring 5 mm x 5 mm x 5 mm. tracking of weight and height curves from birth to age 6
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: early transcriptomic markersExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
transcriptomic markers in children under 4 years of age that predict a predisposition to being overweight at age 6 (BMI > IOTF25).
Ranking of the discriminative capacity of adipocyte and blood transcripts before 4 years of age to predict the development of overweight (BMI \> IOTF25) at age 6, using Partial Least Squares Discriminant Analysis (PLS-DA).
Time frame
perioperativeSecondary outcomes
1
analyze weight trajectories
Selection and validation of transcriptomic markers for the development of a predictive score for the risk of overweight and obesity in children
Time frame
at age 6 years2
molecular and epigenetic mechanisms associated with the identified transcriptomic signatures.
methylation profiles
Time frame
at the time of blood ans adipose tissu sampling3
comparison of transcriptomic expression levels between blood and adipose tissue
percentage of common markers sampled from blood and adipose tissue
Time frame
perioperative4
develop a quantitative test based on digital PCR to define individual expression thresholds predictive of risk
Performance of the digital PCR test evaluated by the ability to discriminate weight trajectories (AUC of ROC curves).
Time frame
at age 6 yearsSponsors and contacts
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Source ClinicalTrials.gov
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