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

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05835089
Collaborator
(none)
50
1
12
4.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: serum kisspeptin levels

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Evaluation of Some-puberty Related Hormones Among Children and Adolescents With Chronic Kidney Diseases
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm 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)
  • Outcome Measures

    Primary Outcome Measures

    1. The serum level of Kisspeptin levels [one year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 18 Years
    Sexes Eligible for Study:
    All

    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.

    -

    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.

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sohag University Hospital Sohag Egypt

    Sponsors and Collaborators

    • Sohag University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Heba Mohamed Ahmed, resident doctor at pediatrics department, Sohag University
    ClinicalTrials.gov Identifier:
    NCT05835089
    Other Study ID Numbers:
    • Soh-Med-23-04-18MS
    First Posted:
    Apr 28, 2023
    Last Update Posted:
    Apr 28, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 28, 2023