跳至主要内容
临床试验/NCT05835089
NCT05835089尚未招募不适用

Evaluation of Some-puberty Related Hormones Among Children and Adolescents With Chronic Kidney Diseases

Sohag University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年5月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
The serum level of Kisspeptin levels

研究概览

简要总结

Puberty is the process of transition from childhood into adolescence, signaling the readiness of the human body for reproduction. The Hypothalamic-Pituitary Gonadotropin axis plays the primary role in initiating the puberty, where the hypothalamus secrets gonadotropin releasing hormone (GnRH) in a pulsatile manner, which in turn stimulates the release of luteinizing hormone (LH), and follicle stimulating hormone (FSH) from the anterior lobe of the pituitary gland, and in a final step these hormones stimulate the gonads to release their sex hormones (Testosterone and Estradiol) .

Chronic illnesses can affect this physiological process resulting in delayed puberty . Delayed puberty is defined as the lack of pubertal signs until the age of 13 years in girls, and the age of 14 years in boys. Delayed puberty is classified into two categories according to their cause; central gonadotropin deficiency (hypogonadotropic hypogonadism) and this type comprises delayed puberty due to chronic illness, while the second category of delayed puberty is due to gonadal disorders (hypergonadotropic hypogonadism).

Delayed puberty is common among pediatric patients with chronic kidney disease (CKD) - where glomerular filtration rate (GFR) is less than 60 ml/min per 1.73 m2. Previous studies suggested that, the cyclic pattern of GnRH release is lost in patients with CKD resulting in impairment of gonadotropins secretion from the anterior pituitary gland. Multiple hormonal factors had been proposed to be responsible for the pubertal delay in patients with CKD, the most prominent of which is the increasing levels of prolactin, LH and GnRH (4). Prolactin normally inhibits the release of GnRH from hypothalamus thus inhibiting the initiation of puberty and it was found to increase in patients with CKD secondary to increased production, slightly decreased clearance and decreased responsiveness to the hypothalamic inhibition of prolactin secretion.

Furthermore, recent studies reported that the Kisspeptin protein play an important role in the regulation and control of normal puberty, As it was found that the Kisspeptin neurons (the rostral periventricular region of the third ventricle (RP3V) and arcuate nucleus (ARC), are found in close association with the GnRH releasing neurons in the hypothalamus suggesting that these neurons might play a crucial role in activating and restoring the pulsatile release of GnRH, It was also found that inactivating mutations of the gene encoding for kisspeptin were associated with hypogonadotropic hypogonadism.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children and Adolescents aged 8 to 18 years, diagnosed with CKD and attending the pediatric nephrology clinic and the pediatric dialysis unit at Sohag University Hospital will be included.
  • In addition, Age- and sex-matched controls will be included from children and adolescents attending the general pediatric clinic at Sohag University Hospital for acute non-serious illnesses.

排除标准

  • Pediatric post-renal transplant recipients and patients receiving hormonal replacement therapy for endocrinopathies and cases with any other associated chronic illness will be excluded from the study.

结局指标

主要结局

The serum level of Kisspeptin levels

时间窗: one year

The serum level of Kisspeptin levels will be measured for all the study participants.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heba Mohamed Ahmed

resident doctor at pediatrics department

Sohag University

研究点 (1)

Loading locations...

相似试验