Age-dependent Changes in the Responsiveness of Hypothalamic Pituitary Gonadal Axis in Men

October 19, 2017 updated by: Ghulam Nabi, Quaid-e-Azam University

Age-dependent Changes in the Responsiveness of Hypothalamic Pituitary Gonadal Axis to Kisspeptin-10 Administration in Men

The present study was designed to assess the responsiveness of the hypothalamic pituitary gonadal axis to kisspeptin administration with increasing age in men.

Study Overview

Status

Completed

Detailed Description

Little is known about the involvement of kisspeptin signalling in the causation of senescence-basal modulation of the GnRH-LH unit in any model and particularly in advance age men. The present study was therefore designed to assess the response of hypothalamic pituitary gonadal axis to kisspeptin administration with increasing age in healthy men. Sequential blood samples (2 ml) were obtained for 30 minutes pre and 120 minutes post-kisspeptin injection periods at 30 min intervals (-30, 0, 30, 60, 90, 120). Kisspeptin-10 was administered (1 µg/kg BW) as an intravenous bolus, immediately after collecting 0 min sample to assess the response of GnRH neurons to kisspeptin-10 with increasing age in men by determining plasma levels of LH and testosterone.

Study Type

Interventional

Enrollment (Actual)

15

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

      • 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

23 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

• Age

Exclusion Criteria:

  • Hepatic and renal complications
  • Epilepsy
  • Pneumonia
  • Asthma
  • Orchitis
  • Hernia
  • Cryptorchidism
  • Cardiovascular diseases
  • Reproductive disorders
  • Mental retardation

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: Adult men
The average age was 25.80±0.37 years and intervention human kisspeptin-10 was administered in single iv bolus dose (1 µg/kg BW). Serial blood samples were collected for 30 min pre and 120 min post-kisspeptin injection periods at 30 min interval.
Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) is a potent HPG-axis stimulator and control reproduction.
Experimental: Middle age men
The average age was 47.00±0.77 years and intervention human kisspeptin-10 was administered in single iv bolus dose (1 µg/kg BW). Serial blood samples were collected for 30 min pre and 120 min post-kisspeptin injection periods at 30 min interval.
Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) is a potent HPG-axis stimulator and control reproduction.
Experimental: Advance age men
The average age was 73.20±0.91 years and intervention human kisspeptin-10 was administered in single iv bolus dose (1 µg/kg BW). Serial blood samples were collected for 30 min pre and 120 min post-kisspeptin injection periods at 30 min interval.
Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) is a potent HPG-axis stimulator and control reproduction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To investigate the basal function of KISS1R on GnRH neurons through serum LH and testosterone during aging in men
Time Frame: Two blood samples at 30 minutes interval before kisspeptin injection were obtained from all the groups to determine basal levels for LH and testosterone.
Two blood samples at 30 minutes interval before kisspeptin injection were obtained from all the groups to determine basal levels for LH and testosterone.
Changes in the sensitivity of KISS1R by determining the responsiveness of GnRH neuron to kisspeptin administration after 30 minutes during aging in men through measuring plasma luteinizing hormone and testosterone concentrations
Time Frame: One blood sample from all individuals were obtained after 30 minutes of post kisspeptin injection for measuring a change in LH and testosterone.
One blood sample from all individuals were obtained after 30 minutes of post kisspeptin injection for measuring a change in LH and testosterone.
Changes in the sensitivity of KISS1R by determining the responsiveness of GnRH neuron to kisspeptin administration after 60 minutes during aging in men through measuring plasma luteinizing hormone and testosterone concentrations
Time Frame: One blood sample from all individuals were obtained after 60 minutes of post kisspeptin injection for measuring a change in LH and testosterone.
One blood sample from all individuals were obtained after 60 minutes of post kisspeptin injection for measuring a change in LH and testosterone.
Changes in the sensitivity of KISS1R by determining the responsiveness of GnRH neuron to kisspeptin administration after 90 minutes during aging in men through measuring plasma luteinizing hormone and testosterone concentrations
Time Frame: One blood sample from all individuals were obtained after 90 minutes of post kisspeptin injection for measuring a change in LH and testosterone.
One blood sample from all individuals were obtained after 90 minutes of post kisspeptin injection for measuring a change in LH and testosterone.
Changes in the sensitivity of KISS1R by determining the responsiveness of GnRH neuron to kisspeptin administration after 120 minutes during aging in men through measuring plasma luteinizing hormone and testosterone concentrations
Time Frame: One blood sample from all individuals were obtained after 120 minutes of post kisspeptin injection for measuring a change in LH and testosterone.
One blood sample from all individuals were obtained after 120 minutes of post kisspeptin injection for measuring a change in LH and testosterone.

Collaborators and Investigators

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

Investigators

  • Study Chair: Shahab, 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.

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)

August 8, 2014

Primary Completion (Actual)

August 10, 2014

Study Completion (Actual)

March 5, 2015

Study Registration Dates

First Submitted

September 30, 2017

First Submitted That Met QC Criteria

October 16, 2017

First Posted (Actual)

October 20, 2017

Study Record Updates

Last Update Posted (Actual)

October 23, 2017

Last Update Submitted That Met QC Criteria

October 19, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Quaid-i-Azam University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

After publishing will be available to all researchers. Additional data will be provided by the corresponding author on 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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