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Completed

NCT Number: NCT03286517

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

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.

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Key information

Conditions

Reproductive Physiological Phenomena Behavior Sexual Behavior Sexuality

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Quaid-i-Azam University

Islamabad, 45320, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Biological

A neurohormone

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.

Sponsors and collaborators

Lead sponsor

Ghulam Nabi

Other

Registry information

Official study title

Changes in the Responsiveness of the Hypothalamic-pituitary-gonadal (HPG) Axis to Kisspeptin-10 Administration During Pubertal Transition in Boys

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 18, 2017
Registry last updated
Sep 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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