Evaluation of Some Puberty-related Hormones Among Children and Adolescents With Chronic Kidney Diseases

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Evaluation of Some Puberty-related Hormones Among Children and Adolescents With Chronic Kidney Diseases
• Intervention / Treatment: Diagnostic test: serum kisspeptin levels

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Heba A Mohamed, resident; Phone Number: 01094215946; Email: heba_muhammad_post@med.sohag.edu.eg
• Study Contact Backup: Name: Ahmed Mohamed H Monir, associate professor; Phone Number: 01097840928; Email: ahmed_hegab@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag university Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Children and Adolescents aged 8 to 18 years, diagnosed with CKD

Description

Inclusion Criteria: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.

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Exclusion Criteria: 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.

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
children and adolescents with chronic kidney diseases; The serum level of LH, FSH, prolactin, Testosterone (in boys), estradiol (in girls) and Kisspeptin levels will be measured for all the study participants.	Diagnostic test: serum kisspeptin levels; Evaluation of the serum level of LH, FSH, prolactin, Testosterone (in boys), estradiol (in girls) and Kisspeptin levels; Other Names: The serum level of LH, FSH, prolactin, Testosterone (in boys), estradiol (in girls)
control group of patients; The serum level of LH, FSH, prolactin, Testosterone (in boys), estradiol (in girls) and Kisspeptin levels will be measured for all the study participants.	Diagnostic test: serum kisspeptin levels; Evaluation of the serum level of LH, FSH, prolactin, Testosterone (in boys), estradiol (in girls) and Kisspeptin levels; Other Names: The serum level of LH, FSH, prolactin, Testosterone (in boys), estradiol (in girls)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The serum level of Kisspeptin levels	The serum level of Kisspeptin levels will be measured for all the study participants.	one year

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Levey AS, Eckardt KU, Tsukamoto Y, Levin A, Coresh J, Rossert J, De Zeeuw D, Hostetter TH, Lameire N, Eknoyan G. Definition and classification of chronic kidney disease: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2005 Jun;67(6):2089-100. doi: 10.1111/j.1523-1755.2005.00365.x.
• Brook CG. Mechanism of puberty. Horm Res. 1999;51 Suppl 3:52-4. doi: 10.1159/000053162.
• Pozo J, Argente J. Delayed puberty in chronic illness. Best Pract Res Clin Endocrinol Metab. 2002 Mar;16(1):73-90. doi: 10.1053/beem.2002.0182.
• Holley JL. The hypothalamic-pituitary axis in men and women with chronic kidney disease. Adv Chronic Kidney Dis. 2004 Oct;11(4):337-41.
• Harter CJL, Kavanagh GS, Smith JT. The role of kisspeptin neurons in reproduction and metabolism. J Endocrinol. 2018 Sep;238(3):R173-R183. doi: 10.1530/JOE-18-0108.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Androgens; Estradiol; Testosterone
• Other Study ID Numbers: Soh-Med-23-04-18MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No