Obesity (Disorder)REOPNCT07545174
Role of the Environment in Pediatric Obesity
A study testing Blood test, Urine sample and Hair sample in people with Obesity (Disorder), run by University Hospital, Tours at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity (Disorder)
- What is being tested?
- Blood test, Urine sample and Hair sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- Disorder preventing understanding of trial information or informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
CHRU de Tours
Tours
Julien LEJEUNE, +332 47 47 72 34, j.leujeune@chu-tours.fr
Julien LEJEUNE
CHRU de Tours
Tours
Karine BERNARDO, +332 47 47 78 28, k.bernardo@chu-tours.fr
Karine BERNARDO
About this study
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.
Read more
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.
- Conditions
- Obesity (Disorder)
- Being tested
- Blood test, Urine sample, Hair sample
- Keywords
- Obesity, PFAS, Environment
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testOther
Inclusion visit: during the routine blood test, one additional tube of blood will be collected for the study.
Urine sampleOther
Inclusion visit: a urine sample will be collected for the study.
Hair sampleOther
Inclusion visit: a hair sample will be taken from the patient.
| Study group | Role | What they receive |
|---|---|---|
| Obesity disorder | Other | Patient with Obesity disorder Receives: Other: Blood test; Other: Urine sample; Other: Hair sample |
| Control | Other | Control group: patient without obesity disorder Receives: Other: Blood test; Other: Urine sample; Other: Hair sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the enrollment visit
Secondary outcomes (6)
PFOS concentration
Difference in plasma concentration of perfluorooctane sulfate (PFOS) measured in ng/mL between obese children and non-obese children.
Measured: At the enrollment visit
PFNA concentration
Difference in plasma concentration of perfluorononanoic acid (PFNA) measured in ng/mL between obese children and non-obese children
Measured: At the enrollment visit
PFHxS concentration
Difference in plasma concentration of perfluorohexanesulfonic acid (PFHxS) measured in ng/mL between obese children and non-obese children.
Measured: At the enrollment visit
BPA concentration
Differences in urinary BPA concentrations measured in ng/mL between obese and non-obese children
Measured: At the enrollment visit
Non-persistent pesticides concentration
Differences in urinary concentrations of non-persistent pesticides (organophosphates and polychlorinated biphenyls) in ng/mL between obese and non-obese children
Measured: At the enrollment visit
Number of DNA breaks
Differences in the number of DNA breaks in hair follicles between obese and non-obese children
Measured: At the enrollment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (Disorder)Studies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545174
- Sponsor's protocol ID
- DR240165
- Other IDs
- 2025-A01227-42
- Acronym
- REOP
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Environment in Pediatric Obesity
- ClinicalTrials.gov ID
- NCT07545174
- Acronym / sponsor ID
- REOP / DR240165
- Conditions
- Obesity (Disorder)
- Keywords
- Obesity, PFAS, Environment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obesity disorder | Other | Other: Blood test, Other: Urine sample, Other: Hair samplePatient with Obesity disorder |
| Control | Other | Other: Blood test, Other: Urine sample, Other: Hair sampleControl group: patient without obesity disorder |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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)
- Whose two parents, or legal guardian, have signed an informed consent form
Key exclusion criteria (1 listed)
- Disorder preventing understanding of trial information or informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testInclusion visit: during the routine blood test, one additional tube of blood will be collected for the study. | Other | Control, Obesity disorder |
| Urine sampleInclusion visit: a urine sample will be collected for the study. | Other | Control, Obesity disorder |
| Hair sampleInclusion visit: a hair sample will be taken from the patient. | Other | Control, Obesity disorder |
Primary outcome
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.
6 secondary outcomes
PFOS concentration
Time frame: At the enrollment visit
PFNA concentration
Time frame: At the enrollment visit
PFHxS concentration
Time frame: At the enrollment visit
BPA concentration
Time frame: At the enrollment visit
Non-persistent pesticides concentration
Time frame: At the enrollment visit
Number of DNA breaks
Time frame: At the enrollment visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test, Urine sample and Hair sample in people with Obesity (Disorder), run by University Hospital, Tours at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien LEJEUNE (+332 47 47 72 34, j.leujeune@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFOA concentration (time frame: At the enrollment visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.