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

Ghulam Nabi

Status and phase: Completed; Phase 3

Conditions: Reproductive Physiological Phenomena

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03286517

QuaideAzamU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Male

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 6 patient groups

Tanner Stage I

Experimental group

Description:

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.

Treatment:

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

Tanner Stage II

Experimental group

Description:

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.

Treatment:

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

Tanner Stage III

Experimental group

Description:

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.

Treatment:

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

Tanner Stage IV

Experimental group

Description:

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.

Treatment:

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

Tanner stage V

Experimental group

Description:

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.

Treatment:

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

Adult Group

Experimental group

Description:

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.

Treatment:

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