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临床试验/NCT03700515
NCT03700515Unknown不适用

Exosome Proteomics to Detect Eyrthropoietin (EPO) Use in Athletes

Morten Hostrup, PhD1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2019年9月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
72
试验地点
1
主要终点
Blood proteome enrichment pathway analysis in GO annotation

研究概览

简要总结

The role of exosomes in cell signalling has only recently been appreciated and is a hugely exciting and rapidly growing area, and combined with LC-MS/MS proteomics, can overcome traditional barriers to proteomics in doping applications. To our knowledge, no research has yet been undertaken to explore whether the highly promising combination of exosome proteomics has utility for rhEPO detection. The applications are extensive; the diagnostic value of differentially regulated proteins could be further validated against the existing IEF EPO WADA accredited tests using samples collected during this study, used to study altitude hypoxia versus exogenous EPO administration (WADA current targeted research 2017), investigated as a platform approach to ESA and HIF agents more generally, as well as facilitate development of direct ELISA high throughput tests.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • VO2max of at least 55+/-2 for men and 50+/-2 for women
  • BMI between 18 and 27
  • Resting hematocrit of less than 46%

排除标准

  • Chronic disease deemed by the medical doctor to affect the outcome
  • Competitive athlete subject to doping control
  • Use of other prescription medicine deemed by the medical doctor to interact with the study drug
  • Allergy or otherwise unacceptable side effects toward the study drug
  • Pregnancy

研究组 & 干预措施

EPO II

Experimental

Erythropoetin infusion (20 IU/kg)

干预措施: Erythropoietin (Drug)

Placebo

Placebo Comparator

Saline infusion

干预措施: Placebo (Drug)

EPO

Experimental

Erythropoetin infusion (9 IU/kg)

干预措施: Erythropoietin (Drug)

结局指标

主要结局

Blood proteome enrichment pathway analysis in GO annotation

时间窗: At baseline and after week 3 of treatment

Change in enrichment (measured in blood and assessed using GO annotation)

次要结局

  • Blood markers of iron(At baseline and after week 3 of treatment)

研究者

发起方
Morten Hostrup, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Morten Hostrup, PhD

Associate Professor

University of Copenhagen

研究点 (1)

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