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临床试验/NCT01320449
NCT01320449已完成不适用

Identification of New Serum Markers for Detection of Abuse With Erythropoietin

University of Aarhus2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Changes in serum protein isoforms measured by proteomics

研究概览

简要总结

Epo increases red blood cell production and hence the amount of oxygen that can be transported around the body. It is shown that prolonged use of synthetic Epo (rHuEpo) leads to an increase in the period of time a given physical work can be performed, therefore it will continue to be abused by athletes, especially in endurance sports.

The existing method for measuring the abuse of rHuEpo approved by the World Anti-Doping Agency (WADA) is based on differences in the sugar groups bound to rHuEpo and Epo produced in the body, respectively.

Proteomics is a method by which one can look at all the proteins in blood at the same time. Even proteins that have changed very little can be distinguished. The main objective of this project is to investigate the effect of prolonged treatment with rHuEpo on changes in blood proteins in healthy young men.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • healthy men
  • age 18-35
  • untrained
  • BMI: 20-25

排除标准

  • chronic diseases
  • malignancy (former or present)
  • alcohol, drug or EPO abuse

研究组 & 干预措施

No training + placebo

Placebo Comparator

10 young men being investigated with 10 weeks apart. The will receive placebo injections twice a week. Blood samples, blood pressures as well as VO2-max tests will be obtained during the 10 weeks.

干预措施: Placebo (Other)

No training + EPO

Active Comparator

10 young men being investigated with 10 weeks apart. During the 10 weeks participants will receive EPO injections twice a week. Blood samples, blood pressures as well as VO2-mas tests will be obtained during the 10 weeks.

干预措施: recombinant human erythropoietin (Drug)

Training + placebo

Active Comparator

10 young men will be trained for 10 weeks and investigated before and after. They will receive placebo injections twice a week. Blood samples, blood pressures as well as VO2-max tests will be obtained during the 10 weeks.

干预措施: Training (Behavioral)

Training + placebo

Active Comparator

10 young men will be trained for 10 weeks and investigated before and after. They will receive placebo injections twice a week. Blood samples, blood pressures as well as VO2-max tests will be obtained during the 10 weeks.

干预措施: Placebo (Other)

Training + EPO

Active Comparator

10 young men will be investigated with 10 weeks apart. During the ten weeks they will train 3 times a week and receive EPO injections twice a week. Blood samples, blood pressures as well as VO2-max tests will be obtained during the 10 weeks.

干预措施: recombinant human erythropoietin (Drug)

Training + EPO

Active Comparator

10 young men will be investigated with 10 weeks apart. During the ten weeks they will train 3 times a week and receive EPO injections twice a week. Blood samples, blood pressures as well as VO2-max tests will be obtained during the 10 weeks.

干预措施: Training (Behavioral)

结局指标

主要结局

Changes in serum protein isoforms measured by proteomics

时间窗: 10 months

We wish to identify proteins or isoforms hereof that change with rHuEpo treatment, in order to identify new biomarkers in the blood that can be used to detect rHuEpo abuse.

次要结局

  • Changes in substrate metabolism in relation to rHuEpo treatment and endurance training(10 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Birgitte Nellemann

MD PhDstudent

University of Aarhus

研究点 (2)

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