Role of the Environment in Pediatric Obesity
ConditionObesity (Disorder)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-15
SponsorUniversity Hospital, Tours
About this trial
Childhood obesity is a particular concern in developed countries such as the United States, the United Kingdom, Canada, and certain European countries. According to the World Health Organization (WHO), approximately 6% of children under the age of 5 worldwide were obese in 2016, a figure that continues to rise.
The pathophysiology of pediatric obesity can be explained by several interconnected biological and behavioral mechanisms. In particular, it involves dysfunctions in the hormones that regulate appetite and satiety, as well as dysfunctions in lipid metabolism.
Per- and polyfluoroalkyl substances (PFAS) are a large family of synthetic chemical compounds. The main PFAS are perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), perfluorononanoic acid (PFNA), and perfluorohexanesulfonic acid (PFHxS). PFAS are present in many everyday consumer products.
Bisphenol A (BPA) is a chemical compound used primarily in the manufacture of plastics and resins. It is commonly found in polycarbonate plastics, used to make food containers and water bottles, as well as in epoxy resins, which are used to coat the inside of food cans and water pipes.
Non-persistent pesticides, such as organophosphates and polychlorinated biphenyls, are chemicals used primarily in agriculture to control insects and other pests.
There are arguments suggesting that PFAS, bisphenol A, and non-persistent pesticides may play a role in the onset of pediatric obesity, particularly by acting.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Children with obesity (according to the BMI curves of the International Obesity Task Force/IOTF)
Follow-up within the obesity network of the Centre Val de Loire region (ObeCentre)
Children who are not obese (according to the BMI curves of the International Obesity Task Force/IOTF)
Children aged 6 to 15 at the time of inclusion (inclusive)
Disqualifiers
Disorder preventing understanding of trial information or informed consent.
Trial design
Design model
Parallel
Treatments tested in this trial
Blood test
Other interventionInclusion visit: during the routine blood test, one additional tube of blood will be collected for the study.
Urine sample
Other interventionInclusion visit: a urine sample will be collected for the study.
Hair sample
Other interventionInclusion visit: a hair sample will be taken from the patient.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Obesity disorderOther 3 interventions
Group B: ControlOther 3 interventions
Trial outcomes
Primary outcomes
1
PFOA concentration
Difference in plasma PFOA concentration measured in ng/mL between obese and non-obese children (control group). PFOA will be measured in plasma using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) at the Laberca laboratory.
Time frame
At the enrollment visitSecondary outcomes
1
PFOS concentration
Difference in plasma concentration of perfluorooctane sulfate (PFOS) measured in ng/mL between obese children and non-obese children.
Time frame
At the enrollment visit2
PFNA concentration
Difference in plasma concentration of perfluorononanoic acid (PFNA) measured in ng/mL between obese children and non-obese children
Time frame
At the enrollment visit3
PFHxS concentration
Difference in plasma concentration of perfluorohexanesulfonic acid (PFHxS) measured in ng/mL between obese children and non-obese children.
Time frame
At the enrollment visit4
BPA concentration
Differences in urinary BPA concentrations measured in ng/mL between obese and non-obese children
Time frame
At the enrollment visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: