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

Phase 3

Completed

• Conditions: Sterility, Reproductive
• Interventions: Biological: Human kisspeptin-10 (metastin 45-54)

• Registration Number: NCT03315325
• Lead Sponsor: Quaid-e-Azam University

Brief Summary

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

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 Timeline

• Study Start: 2014-08-08
• Primary Completion: 2014-08-10
• Study Completion: 2015-03-05
• Study First Submitted: 2017-09-30
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-16
• Last Update Submitted: 2017-10-19
• Study First Posted: 2017-10-20
• Last Update Posted: 2017-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

• Age

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Middle age men	Human kisspeptin-10 (metastin 45-54)	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.
Adult men	Human kisspeptin-10 (metastin 45-54)	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.
Advance age men	Human kisspeptin-10 (metastin 45-54)	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.

Primary Outcome Measures

Name	Time	Method
To investigate the basal function of KISS1R on GnRH neurons through serum LH and testosterone during aging in men	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	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	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	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	One blood sample from all individuals were obtained after 120 minutes of post kisspeptin injection for measuring a change in LH and testosterone.

Trial Locations

Locations (1)

Quaid-i-Azam University; 🇵🇰 Islamabad, Pakistan