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临床试验/NCT07545174
NCT07545174尚未招募不适用

Role of the Environment in Pediatric Obesity

University Hospital, Tours1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
PFOA concentration

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
6 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Disorder preventing understanding of trial information or informed consent.

研究组 & 干预措施

Obesity disorder

Other

Patient with Obesity disorder

干预措施: Blood test (Other)

Obesity disorder

Other

Patient with Obesity disorder

干预措施: Urine sample (Other)

Obesity disorder

Other

Patient with Obesity disorder

干预措施: Hair sample (Other)

Control

Other

Control group: patient without obesity disorder

干预措施: Blood test (Other)

Control

Other

Control group: patient without obesity disorder

干预措施: Urine sample (Other)

Control

Other

Control group: patient without obesity disorder

干预措施: Hair sample (Other)

结局指标

主要结局

PFOA concentration

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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