Role of the Environment in Pediatric Obesity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University Hospital, Tours
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- PFOA concentration
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patient with Obesity disorder :
- •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)
- •Control group:
- •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)
- •Whose two parents, or legal guardian, have signed an informed consent form
- •Patients affiliated with or covered by a social security system
Exclusion Criteria
- •Disorder preventing understanding of trial information or informed consent.
Arms & Interventions
Obesity disorder
Patient with Obesity disorder
Intervention: Blood test (Other)
Obesity disorder
Patient with Obesity disorder
Intervention: Urine sample (Other)
Obesity disorder
Patient with Obesity disorder
Intervention: Hair sample (Other)
Control
Control group: patient without obesity disorder
Intervention: Blood test (Other)
Control
Control group: patient without obesity disorder
Intervention: Urine sample (Other)
Control
Control group: patient without obesity disorder
Intervention: Hair sample (Other)
Outcomes
Primary Outcomes
PFOA concentration
Time Frame: At the enrollment visit
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.
Secondary Outcomes
- PFOS concentration(At the enrollment visit)
- PFNA concentration(At the enrollment visit)
- PFHxS concentration(At the enrollment visit)
- BPA concentration(At the enrollment visit)
- Non-persistent pesticides concentration(At the enrollment visit)
- Number of DNA breaks(At the enrollment visit)