跳至主要内容
临床试验/CTRI/2024/03/064073
CTRI/2024/03/064073尚未招募不适用

Association of endocrine disruptors (plasticizers) with early puberty in Indian children.

Department of Health Research2 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
171
试验地点
2
主要终点
Urinary and serum levels of plasticizer like bisphenol-A, plasma phthalate in cases and controls

研究概览

简要总结

A secular trend in the age of Pubertal onset is discernible globally. One of the implicated factors other than nutrition and genetics includes exogenous compounds with endocrine active properties that interfere with endogenous hormone action. These Endocrine Disrupting Compounds (EDCs) can bind hormone receptors and affect their synthesis, transport, metabolism, and/or elimination. This study is planned to compare the levels of these plasticizers in children who demonstrated features of early/ precocious puberty and compare with age-matched healthy controls with normal puberty who reside in the same geographical area. The levels will also be correlated with puberty-governing neuropeptide like Kisspeptin. The study will be a multicentric study that will recruit 31 cases and 62 controls during the study period. All participants will be subjected to urine and blood tests at one point in time. Our study attempts to evaluate the role of EDC exposure on pubertal onset with correction of nutritional status which is a major confounder. It will help us determine a functional impact of EDC status on hypothalamic-pituitary axis by measurement of Kisspeptin levels

研究设计

研究类型
Observational

入排标准

年龄范围
8.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • Cases will be identified as children with either gender who present with early or precocious puberty defined in girls as onset of thelarche, pubarche or adrenarche before 8 years of age and in boys as increase in testicular volume greater than 4mL, pubarche or adrenarche before 9 years of age.
  • Children labeled as idiopathic precocious puberty (due to both central and peripheral causes) will be included as Cases.

排除标准

  • 1.Children born small for gestational age defined as birth weight below 10th centile.
  • 2.Children with organic cause of early or precocious puberty like intracranial malformation, infection, tumors or congenital adrenal hyperplasia or gonadal tumors.
  • 3.Children previously diagnosed with any hormonal disorder or on any steroid drugs.

结局指标

主要结局

Urinary and serum levels of plasticizer like bisphenol-A, plasma phthalate in cases and controls

时间窗: Single point

次要结局

  • Correlation between bisphenol-A, plasma phthalate levels & serum FSH, LH & kisspeptin expression between control & cases
  • Correlation between plasticizer levels & anthropometry & serum leptin levels(Single point)

研究者

发起方
Department of Health Research
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Binita Goswami

Maulana Azad Medical College

研究点 (2)

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