Evaluation of Some Puberty-related Hormones Among Children and Adolescents With Chronic Kidney DiseasesNCT05835089
Evaluation of Some Puberty-related Hormones Among Children and Adolescents With Chronic Kidney Diseases
An observational study of Evaluation of Some Puberty-related Hormones Among Children and Adolescents With Chronic Kidney Diseases, run by Sohag University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Evaluation of Some Puberty-related Hormones Among Children and Adolescents With Chronic Kidney Diseases
- What is being tested?
- serum kisspeptin levels
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- May 2023to May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- Child, Adult
Study population: Children and Adolescents aged 8 to 18 years, diagnosed with CKD
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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Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read more
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.
- Being tested
- serum kisspeptin levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum kisspeptin levelsDiagnostic test
Also called The serum level of LH, FSH, prolactin, Testosterone (in boys), estradiol (in girls)
Evaluation of the serum level of LH, FSH, prolactin, Testosterone (in boys), estradiol (in girls) and Kisspeptin levels
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: serum kisspeptin levels | |
| 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. Receives: Diagnostic Test: serum kisspeptin levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
The serum level of Kisspeptin levels
The serum level of Kisspeptin levels will be measured for all the study participants.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study startMay 2023 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Evaluation of Some Puberty-related Hormones Among Children and Adolescents With Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Mohamed Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835089
- Sponsor's protocol ID
- Soh-Med-23-04-18MS
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brook CG. Mechanism of puberty. Horm Res. 1999;51 Suppl 3:52-4. doi: 10.1159/000053162.
PubMed 10592444Pozo 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.
PubMed 11987900Levey 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.
PubMed 15882252Holley JL. The hypothalamic-pituitary axis in men and women with chronic kidney disease. Adv Chronic Kidney Dis. 2004 Oct;11(4):337-41.
PubMed 15492969Harter 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.
PubMed 30042117
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Some-puberty Related Hormones Among Children and Adolescents With Chronic Kidney Diseases
- ClinicalTrials.gov ID
- NCT05835089
- Acronym / sponsor ID
- Soh-Med-23-04-18MS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children and adolescents with chronic kidney diseases | – | Diagnostic Test: serum kisspeptin levelsThe serum level of LH, FSH, prolactin, Testosterone (in boys), estradiol (in girls) and Kisspeptin levels will be measured for all the study participants. |
| control group of patients | – | Diagnostic Test: serum kisspeptin levelsThe serum level of LH, FSH, prolactin, Testosterone (in boys), estradiol (in girls) and Kisspeptin levels will be measured for all the study participants. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children and Adolescents aged 8 to 18 years, diagnosed with CKD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum kisspeptin levelsAlso: The serum level of LH, FSH, prolactin, Testosterone (in boys), estradiol (in girls)Evaluation of the serum level of LH, FSH, prolactin, Testosterone (in boys), estradiol (in girls) and Kisspeptin levels | Diagnostic test | children and adolescents with chronic kidney diseases, control group of patients |
Primary outcome
The serum level of Kisspeptin levels
Time frame: one year
The serum level of Kisspeptin levels will be measured for all the study participants.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Background: PubMed 10592444Brook CG. Mechanism of puberty. Horm Res. 1999;51 Suppl 3:52-4. doi: 10.1159/000053162.
- Background: PubMed 11987900Pozo 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.
- Background: PubMed 15882252Levey 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.
- Background: PubMed 15492969Holley JL. The hypothalamic-pituitary axis in men and women with chronic kidney disease. Adv Chronic Kidney Dis. 2004 Oct;11(4):337-41.
- Background: PubMed 30042117Harter 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Evaluation of Some Puberty-related Hormones Among Children and Adolescents With Chronic Kidney Diseases, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heba A Mohamed, resident (01094215946, heba_muhammad_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The serum level of Kisspeptin levels (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05835089, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.