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

NCT ID: NCT03286517

Last Updated: 2017-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-26

Study Completion Date

2015-03-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Reproductive Physiological Phenomena

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

All the groups were injected with exogenous IV kisspeptin according to the body weight.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

All the participants were told for injecting the kisspeptin.

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

A neurohormone

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.

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

A neurohormone

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.

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

A neurohormone

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.

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

A neurohormone

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.

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

A neurohormone

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.

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

A neurohormone

Interventions

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

A neurohormone

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

* 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
Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ghulam Nabi

OTHER

Sponsor Role lead

Responsible Party

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Ghulam Nabi

Mr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Muhammad Shahab, PhD

Role: STUDY_DIRECTOR

Quaid-i-Azam University

Locations

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Quaid-i-Azam University

Islamabad, , Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 17023533 (View on PubMed)

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.

Reference Type RESULT
PMID: 21976724 (View on PubMed)

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.

Reference Type RESULT
PMID: 19820030 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30046307 (View on PubMed)

Study Documents

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Document Type: Any information required can be provided

Prof. Muhammad Shahab will provide the information upon request.

View Document

Other Identifiers

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QuaideAzamU

Identifier Type: -

Identifier Source: org_study_id