Association of endocrine disruptors (plasticizers) with early puberty in Indian children.
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
Dr Binita Goswami
Maulana Azad Medical College
