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

September 13, 2017 updated by: Ghulam Nabi

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 45320
        • Quaid-i-Azam University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
A neurohormone
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)
A neurohormone
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)
A neurohormone
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)
A neurohormone
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)
A neurohormone
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)
A neurohormone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ghulam Nabi

Investigators

  • Study Director: Muhammad Shahab, PhD, Quaid-i-Azam University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2014

Primary Completion (Actual)

August 8, 2014

Study Completion (Actual)

March 5, 2015

Study Registration Dates

First Submitted

September 11, 2017

First Submitted That Met QC Criteria

September 13, 2017

First Posted (Actual)

September 18, 2017

Study Record Updates

Last Update Posted (Actual)

September 18, 2017

Last Update Submitted That Met QC Criteria

September 13, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • QuaideAzamU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual response to kisspeptin administration without disclosing the identity of an individual can be shared with other researchers.

IPD Sharing 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.

IPD Sharing Access Criteria

Will be available on journal website after publication or we can share personally.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Study Data/Documents

  1. Any information required can be provided
    Information comments: Prof. Muhammad Shahab will provide the information upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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