NCT07545174

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
37mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

April 15, 2026

Last Update Submit

April 15, 2026

Conditions

Keywords

ObesityPFASEnvironment

Outcome Measures

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.

    At the enrollment visit

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Obesity disorder

OTHER

Patient with Obesity disorder

Other: Blood testOther: Urine sampleOther: Hair sample

Control

OTHER

Control group: patient without obesity disorder

Other: Blood testOther: Urine sampleOther: Hair sample

Interventions

Inclusion visit: during the routine blood test, one additional tube of blood will be collected for the study.

ControlObesity disorder

Inclusion visit: a urine sample will be collected for the study.

ControlObesity disorder

Inclusion visit: a hair sample will be taken from the patient.

ControlObesity disorder

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)
  • All:
  • Whose two parents, or legal guardian, have signed an informed consent form
  • Patients affiliated with or covered by a social security system

You may not qualify if:

  • Disorder preventing understanding of trial information or informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHRU de Tours

Tours, France

Location

CHRU de Tours

Tours, France

Location

MeSH Terms

Conditions

Obesity

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 22, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Last Updated

April 22, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations