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

NCT03286517 | Completed Phase 3 DMC

• 1 other identifier: QuaideAzamU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Reproductive Physiological Phenomena

Keywords

Puberty, Sexuality

Outcome Measures

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

  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.

Study Arms (6)

Tanner Stage I

EXPERIMENTAL

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)

Tanner Stage II

EXPERIMENTAL

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)

Tanner Stage III

EXPERIMENTAL

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)

Tanner Stage IV

EXPERIMENTAL

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)

Tanner stage V

EXPERIMENTAL

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)

Adult Group

EXPERIMENTAL

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

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

A neurohormone

Adult Group; Tanner Stage I; Tanner Stage II; Tanner Stage III; Tanner Stage IV; Tanner stage V

Eligibility Criteria

• Gender Eligibility Details: children were classified into five pubertal stages called Tanner stages on the basis of a genital examination by a physician.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ghulam Nabi: lead

Study Sites (1)

Quaid-i-Azam University

Islamabad, 45320, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 17023533 BACKGROUND

• 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.

  PMID: 21976724 RESULT

• 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.

  PMID: 19820030 RESULT

• 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.

  PMID: 30046307 DERIVED

MeSH Terms

Conditions

Sexuality

Interventions

KISS1 protein, human

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Muhammad Shahab, PhD

  Quaid-i-Azam University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: All the participants were told for injecting the kisspeptin.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Mr.

Model Details: All the groups were injected with exogenous IV kisspeptin according to the body weight.

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 18, 2017
• Study Start: June 26, 2014
• Primary Completion: August 8, 2014
• Study Completion: March 5, 2015
• Last Updated: September 18, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: I have already completed the study and can share the data. It will be available in the form of research paper along with the supplementary materials.
• Access Criteria: Will be available on journal website after publication or we can share personally.

Locations

PA (1)