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

NCT ID: NCT03315325

Last Updated: 2017-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-08

Study Completion Date

2015-03-05

Brief Summary

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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

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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.

Conditions

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Sterility, Reproductive

Keywords

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Aging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Healthy men, 15 in number were selected. These individuals were classified on the basis of their ages in three groups: adult, middle age and advanced aged. Each group comprised of five participants.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

There was no masking. Every individual was told about injecting the kisspeptin, however, they were not informed at the time when kisspeptin was injected.

Study Groups

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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.

Group Type EXPERIMENTAL

Human kisspeptin-10 (metastin 45-54)

Intervention Type BIOLOGICAL

Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) is a potent HPG-axis stimulator and control reproduction.

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.

Group Type EXPERIMENTAL

Human kisspeptin-10 (metastin 45-54)

Intervention Type BIOLOGICAL

Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) is a potent HPG-axis stimulator and control reproduction.

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.

Group Type EXPERIMENTAL

Human kisspeptin-10 (metastin 45-54)

Intervention Type BIOLOGICAL

Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) is a potent HPG-axis stimulator and control reproduction.

Interventions

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Human kisspeptin-10 (metastin 45-54)

Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) is a potent HPG-axis stimulator and control reproduction.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

• Age

Exclusion Criteria

* Hepatic and renal complications
* Epilepsy
* Pneumonia
* Asthma
* Orchitis
* Hernia
* Cryptorchidism
* Cardiovascular diseases
* Reproductive disorders
* Mental retardation
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Quaid-e-Azam University

OTHER

Sponsor Role lead

Responsible Party

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Ghulam Nabi

Doctoral Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shahab

Role: STUDY_CHAIR

Quaid-i-Azam University

Locations

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Quaid-i-Azam University

Islamabad, , Pakistan

Site Status

Countries

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Pakistan

References

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Chan YM, Butler JP, Pinnell NE, Pralong FP, Crowley WF Jr, Ren C, Chan KK, Seminara SB. Kisspeptin resets the hypothalamic GnRH clock in men. J Clin Endocrinol Metab. 2011 Jun;96(6):E908-15. doi: 10.1210/jc.2010-3046. Epub 2011 Apr 6.

Reference Type RESULT
PMID: 21470997 (View on PubMed)

Dhillo WS, Chaudhri OB, Patterson M, Thompson EL, Murphy KG, Badman MK, McGowan BM, Amber V, Patel S, Ghatei MA, Bloom SR. Kisspeptin-54 stimulates the hypothalamic-pituitary gonadal axis in human males. J Clin Endocrinol Metab. 2005 Dec;90(12):6609-15. doi: 10.1210/jc.2005-1468. Epub 2005 Sep 20.

Reference Type RESULT
PMID: 16174713 (View on PubMed)

George JT, Veldhuis JD, Roseweir AK, Newton CL, Faccenda E, Millar RP, Anderson RA. Kisspeptin-10 is a potent stimulator of LH and increases pulse frequency in men. J Clin Endocrinol Metab. 2011 Aug;96(8):E1228-36. doi: 10.1210/jc.2011-0089. Epub 2011 Jun 1.

Reference Type RESULT
PMID: 21632807 (View on PubMed)

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.

Reference Type RESULT
PMID: 21976724 (View on PubMed)

Other Identifiers

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Quaid-i-Azam University

Identifier Type: -

Identifier Source: org_study_id