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CompletedNCT03286517Updated Sep 18, 2017

Link Between the Sensitivity of Kisspeptin Signalling and Pubertal Onset in Boys.

A Phase 3 interventional study of Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) in Reproductive Physiological Phenomena, sponsored by Ghulam Nabi. Completed at 1 site in Pakistan. Open to male participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-18.

Sponsored by Ghulam Nabi · Phase 3, Interventional, and Basic science

Phase
Phase 3
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Sex
Male
01

Study summary

The specific objective of this study was to investigate the sensitivity of Kisspeptin receptor 1 (KISS1R) by determining the responsiveness of GnRH neuron to kisspeptin administration across the pubertal stages and adult group through measuring plasma LH (luteinizing hormone) and testosterone concentrations.

Read the detailed description

No studies in humans are available regarding KISS1R signalling that, whether expression of the KISS1 or KISS1R sensitivity increases during the pubertal transition in boys. Kisspeptin regulates HPG (hypothalamic pituitary gonadal) axis by secreting GnRH that acts on the pituitary gonadotrophs to secrete LH and FSH. But in contrast to pubertal period, juvenile period kisspeptin pulsatility is reduced, that leads to low GnRH pulsatility and low level of plasma LH, FSH and testosterone. The objective of this study was to determine the response of exogenous kisspeptin in various juvenile stages up to puberty and also in the adults by measuring the level of plasma LH and testosterone. This study would help us to determine that whether there is any link between the increased sensitivity of kisspeptin signalling and puberty onset?, Or at what Tanner stage pre pubertal boys enter into puberty.

02

Conditions studied

  • Reproductive Physiological Phenomena

Keywords

  • Puberty, Sexuality
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Boys were classified into 5 different Tanner stages (I-V) according to the criteria of Feingold D. In Atlas of physical diagnosis. Pediatric endocrinology. 2nd ed. Philadelphia. WB Saunders; 1992, pp. 16-19. For comparison, adult men were also recruited.

Exclusion criteria

Exclusion Criteria:

  • Individuals with chronic illness or disorder, i.e. hepatic and renal complications, epilepsy, pneumonia, asthma, orchitis, hernia, cryptorchidism, mental retardation, etc. were excluded from this study
04

Study design

Phase
Phase 3
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Tanner Stage I

    A 1ml blood sample was obtained for 30 minutes pre and 120 minutes post-kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) injection periods at 30 min intervals (-30, 0, 30, 60, 90, 120). The dose was 9.5 µg/BW.

    Biological: Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)

  • Experimental
    Tanner Stage II

    A 1ml blood sample was obtained for 30 minutes pre and 120 minutes post-kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) injection periods at 30 min intervals (-30, 0, 30, 60, 90, 120). The dose was 11.50 µg/BW.

    Biological: Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)

  • Experimental
    Tanner Stage III

    A 1ml blood sample was obtained for 30 minutes pre and 120 minutes post-kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) injection periods at 30 min intervals (-30, 0, 30, 60, 90, 120). The dose was 12.67 µg/BW.

    Biological: Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)

  • Experimental
    Tanner Stage IV

    A 1ml blood sample was obtained for 30 minutes pre and 120 minutes post-kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) injection periods at 30 min intervals (-30, 0, 30, 60, 90, 120). The dose was 15.11 µg/BW.

    Biological: Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)

  • Experimental
    Tanner stage V

    A 1ml blood sample was obtained for 30 minutes pre and 120 minutes post-kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) injection periods at 30 min intervals (-30, 0, 30, 60, 90, 120). The dose was 20.5 µg/BW.

    Biological: Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)

  • Experimental
    Adult Group

    A 1ml blood sample was obtained for 30 minutes pre and 120 minutes post-kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) injection periods at 30 min intervals (-30, 0, 30, 60, 90, 120). The dose was 1 µg/kg.

    Biological: Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)

Interventions

  • BiologicalKisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)

    A neurohormone

05

What researchers measure

Primary outcomes

  1. To investigate the sensitivity of KISS1R by determining the responsiveness of GnRH neuron to kisspeptin administration across the pubertal stages and adult group through measuring plasma luteinizing hormone and testosterone concentrations

    Time frame: A time frame for each individual was 3 hours. Kisspeptin-10 was injected intravenously and the blood samples were collected at 30 minutes intervals for 30 minutes pre and 2 hours post kisspeptin-10 injection through cannula.

06

Study locations

1 site
  • Quaid-i-Azam University
    Islamabad, 45320, Pakistan
07

References and documents

Publications

  • Mead EJ, Maguire JJ, Kuc RE, Davenport AP. Kisspeptins are novel potent vasoconstrictors in humans, with a discrete localization of their receptor, G protein-coupled receptor 54, to atherosclerosis-prone vessels. Endocrinology. 2007 Jan;148(1):140-7. doi: 10.1210/en.2006-0818. Epub 2006 Oct 5. PubMed 17023533 ↗
  • Jayasena CN, Nijher GM, Comninos AN, Abbara A, Januszewki A, Vaal ML, Sriskandarajah L, Murphy KG, Farzad Z, Ghatei MA, Bloom SR, Dhillo WS. The effects of kisspeptin-10 on reproductive hormone release show sexual dimorphism in humans. J Clin Endocrinol Metab. 2011 Dec;96(12):E1963-72. doi: 10.1210/jc.2011-1408. Epub 2011 Oct 5. PubMed 21976724 ↗
  • Jayasena CN, Nijher GM, Chaudhri OB, Murphy KG, Ranger A, Lim A, Patel D, Mehta A, Todd C, Ramachandran R, Salem V, Stamp GW, Donaldson M, Ghatei MA, Bloom SR, Dhillo WS. Subcutaneous injection of kisspeptin-54 acutely stimulates gonadotropin secretion in women with hypothalamic amenorrhea, but chronic administration causes tachyphylaxis. J Clin Endocrinol Metab. 2009 Nov;94(11):4315-23. doi: 10.1210/jc.2009-0406. Epub 2009 Oct 9. PubMed 19820030 ↗
  • Nabi G, Ullah H, Khan S, Wahab F, Duan P, Ullah R, Yao L, Shahab M. Changes in the Responsiveness of the Hypothalamic-Pituitary-Gonadal Axis to Kisspeptin-10 Administration during Pubertal Transition in Boys. Int J Endocrinol. 2018 Jun 26;2018:1475967. doi: 10.1155/2018/1475967. eCollection 2018. PubMed 30046307 ↗

Individual participant data

Plan to share: Yes — Individual response to kisspeptin administration without disclosing the identity of an individual can be shared with other researchers.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

08

Registry details

Key details

Study ID
NCT03286517
Lead sponsor
Ghulam Nabi
Responsible party
Ghulam Nabi (Mr., Quaid-e-Azam University) — Sponsor-investigator
First posted
Sep 18, 2017
Start date
Jun 26, 2014
Primary completion
Aug 8, 2014
Completion
Mar 5, 2015
Last update
Sep 18, 2017

Study contacts

Muhammad Shahab, PhD
study director · Quaid-i-Azam University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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