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临床试验/NCT01969968
NCT01969968已完成不适用

Lipophilic Organic Polluants and Morbid Obesity: Kinetic of the Release and Impact on the Metabolic Syndrome Before and After Bariatric Surgery

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2013年12月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
232
试验地点
2
主要终点
measurement of POPs

研究概览

简要总结

  1. To study the kinetics of release after bariatric surgery of selected polluants stored in adipose tissue, looking for clinical and/or predictive factors
  2. To test the hypothesis of a deleterious effect of this release on the expected improvement of insulin-resistance and on the liver inflammation.
  3. To determine the level of contamination of morbidly obese patients, with or without metabolic syndrome, compared to a control, non obese population, with special attention to clinical (age, gender, reproductive history, pregnancy, nursing) and biological parameters (insulin-resistance, inflammation).

详细描述

I- Goals Because of its exponential prevalence and its co-morbidities, obesity, particularly in its most massive forms, has become a public health problem. It is likely that this epidemic be secondary to both genetic and behavioural factors, and also to environmental factors. Specifically, the "obesogen" and "diabetogen" role of several persistant organic polluants (POP) known as endocrine disruptors used in farming or industry has recently been suggested by experimental animal studies and by human epidemiologic studies. Those chemicals are usually lipophilic, are stored in adipose tissue where they bio-accumulate, and are released in the blood stream during the lipolysis that occurs in any weight loss. This weight loss is particularly rapid and important after bariatric surgery, that is proposed as a treatment for morbid obesity usually leading to an improvement of insulin resistance, metabolic syndrome, and diabetes. However, this improvement is not constant, or is less important than would be anticipated for the massive weight loss observed. This raises the question of the importance and of deleterious impact of the blood release of lipophilic POPs on the evolution of metabolic syndrome and the low grade associated inflammation.

In a prospective, multicentric study, we propose to analyse the kinetic of the release of several POPs during rapid and massive weight loss obtained after bariatric surgery. Those POPs have been chosen for their obesogen or diabetogen properties, reported in vitro or in vivo, for their lipophilic nature, and their ubiquitous presence in the home environment and/or into the food chain: bisphenol A (plastics); tributyltin (fungicide, anti-fouling agent or thermic stabilizant); polybrominated diphenyl ethers (PBDE, fire retardants); perchlorated octanoïd acid and its sulphated compounds (PFOA and PFOS, perfluoroalkyls used as surfactant, lubrifiants, and usted in wrappings); and organochorinated compounds such as: PCB153, representing the polychlorinated bisphenyls (electric isolation); hexachlorobenzene (HBC), and several pesticides: DDE, metabolite of DDT, now banned but with a very long half life, hexachlorocyclohexane (HCH), heptachlor, nanochlor and chlordane used in agriculture.

II- Originality and /or new aspect of the project Though suggested by several experimental studies, the role of POP in human obesity remains largely unknown.

There are no or very few papers on the role in humans of the POPs we have selected, but they are supported by animal experimental studies.

The concept of release in the blood stream after weight loss is recent and deserves to be studied.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18 to 65 years
  • health coverage
  • mentally competent
  • signed consent form
  • stable weight over the last three months
  • Non inclusion criteria :
  • pregnancy
  • insulin treated diabetes
  • significant weight change over the last three months

排除标准

  • 未提供

结局指标

主要结局

measurement of POPs

时间窗: 18 months

Urinary and blood POPs dosage 18 months after bariatric surgery

clinical and biological assessment of metabolic syndrome

时间窗: 18 months after bariatric surgery

blood dosage for clinical and biological assessment of metabolic syndrome including glucose tolerance test 18 months after bariatric surgery

次要结局

  • Total body burden of selected POPs before and after surgery(before surgery and 18 months after surgery)
  • Kinetic profiles of POP release within 18 months following bariatric surgery(18 months following bariatric surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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