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临床试验/NCT03315325
NCT03315325已完成3 期

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

Quaid-e-Azam University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2014年8月8日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
15
试验地点
2
主要终点
To investigate the basal function of KISS1R on GnRH neurons through serum LH and testosterone during aging in men

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

盲法说明

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

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Hepatic and renal complications
  • Pneumonia
  • Cryptorchidism
  • Cardiovascular diseases
  • Reproductive disorders
  • Mental retardation

研究组 & 干预措施

Adult men

Experimental

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.

干预措施: Human kisspeptin-10 (metastin 45-54) (Biological)

Middle age men

Experimental

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.

干预措施: Human kisspeptin-10 (metastin 45-54) (Biological)

Advance age men

Experimental

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.

干预措施: Human kisspeptin-10 (metastin 45-54) (Biological)

结局指标

主要结局

To investigate the basal function of KISS1R on GnRH neurons through serum LH and testosterone during aging in men

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: One blood sample from all individuals were obtained after 120 minutes of post kisspeptin injection for measuring a change in LH and testosterone.

次要结局

未报告次要终点

研究者

发起方
Quaid-e-Azam University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghulam Nabi

Doctoral Researcher

Quaid-e-Azam University

研究点 (2)

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