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临床试验/NCT03771326
NCT03771326已完成3 期

Preliminary Evidence Suggesting That Acute Administration of KP-10 Induces Insulin Secretion in Normal Weight But Not in Obese Men

Quaid-e-Azam University0 个研究点目标入组 14 人开始时间: 2013年10月29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
14
主要终点
Changes in the response of insulin secretion to acute exogenous kisspeptin administration

研究概览

简要总结

Induction of insulin secretion by kisspeptin is observed in mouse, pig, rat, and human islets in vitro and in rats, mice and monkeys in vivo, but its mechanism is not fully clear. The present study was designed to investigate the role of KP-10 on insulin secretion in adult healthy and obese men with insulin resistance. The aim of selection of obese persons for the present study was to investigate the effect of acute KP-10 administration in a metabolically challenged condition where the pancreatic beta cells are already highly activated. The long-term objective of this study was to understand the physiological role of kisspeptin signalling in the regulation of insulin secretion in human health and disease.

研究设计

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

盲法说明

All the individuals were told before the use of Kp-10 administration. however, to avoid psychological effect the exact time was not disclosed.

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Normal BMI
  • Normal renal function
  • Normal liver function
  • Normal blood count

排除标准

  • Disease history
  • Other trauma

研究组 & 干预措施

obese men

Experimental

To the 7 obese men, kisspeptin-10 was intravenously administered (0.5µg/kg BW, prepared under sterile conditions), as a bolus in a volume of 1ml. Blood samples from all the individuals were collected for 30 minutes pre and 120 minutes post-KP-10 administration, at 30 minutes interval. The obtained blood was centrifuged and the plasma insulin was measured by ELISA.

干预措施: Kisspeptin-10 (Biological)

Normal men

Experimental

To the 7 normal BMI mean, kisspeptin-10 was intravenously administered (0.5µg/kg BW, prepared under sterile conditions), as a bolus in a volume of 1ml. Blood samples from all the individuals were collected for 30 minutes pre and 120 minutes post-KP-10 administration, at 30 minutes interval. The obtained blood was centrifuged and the plasma insulin was measured by ELISA.

干预措施: Kisspeptin-10 (Biological)

结局指标

主要结局

Changes in the response of insulin secretion to acute exogenous kisspeptin administration

时间窗: Each participant was studied up to 4 hours. Blood samples from each individual was collected for 30 minutes pre and 120 minutes post KP-10 administration, at 30 minutes interval.

The blood samples were obtained and analysed for insulin by Enzyme Linked Immunosorbent Assay to know the differential response of insulin secretion to exogenous kisspeptin-10 administration in healthy and obese men.

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

Head of Animal Sciences

Quaid-e-Azam University

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