Tracing Changed Production of Red Blood Cells
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Changes in CD59 expression
研究概览
简要总结
In competitive sport, it is illegal to manipulate erythropoiesis. Manipulated erythropoiesis can indirectly be identified by atypical fluctuations in key haematological variables. However, this method also has limitations and as it is known that some athletes still manipulate erythropoiesis it is necessary to develop new and more sensitive detection methods.
The primary purpose of the study is to examine the importance of altered erythropoiesis for surface and intracellular erythrocyte proteins, the number of immature reticulocytes, and for the haematological characteristics of the erythrocyte, such as volume, haemoglobin concentration and concentration of glycosylated haemoglobin, to assess whether these can be used to identify changed erythropoiesis. Furthermore, the aim is to examine whether these parameters are affected by freezer storage of erythrocytes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men
- •18-40 years
- •physical fitness rating more than 50ml/kg/min
- •non-smokers
- •blood pressure <130/90 mmHg
- •hemoglobin concentration 7-10.5 mM.
排除标准
- •Blood donor who has donated blood within the last three months
- •Participation in other concurrent clinical trials
- •To participate in competitive sport during or three months after the study.
研究组 & 干预措施
Treatment group
Recombinant human erythropoietin treatment three times per week for three weeks
干预措施: Recombinant human erythropoietin (Drug)
结局指标
主要结局
Changes in CD59 expression
时间窗: In the period from two weeks before treatment to three weeks after treatment
Treatment induced changes in CD59 expression on red blood cells
Changes in CD55 expression
时间窗: In the period from two weeks before treatment to three weeks after treatment
Treatment induced changes in CD55 expression on red blood cells
Changes in CD47 expression
时间窗: In the period from two weeks before treatment to three weeks after treatment
Treatment induced changes in CD47 expression on red blood cells
Changes in CD71 expression
时间窗: In the period from two weeks before treatment to three weeks after treatment
Treatment induced changes in CD71 expression on red blood cells
Changes in CD35 expression
时间窗: In the period from two weeks before treatment to three weeks after treatment
Treatment induced changes in CD35 expression on red blood cells
Changes in RNA expression
时间窗: In the period from two weeks before treatment to three weeks after treatment
Treatment induced changes in RNA expression in red blood cells
Changes in Mean Cell Volume
时间窗: In the period from two weeks before treatment to three weeks after treatment
Treatment induced changes in Mean Cell Volume distribution of red blood cells
次要结局
- Changes in Mean Cell Volume cryopreserved(Cryopreserved cells are measured 6 months after sample collection)
- Continous blood glucose levels(In the period from two weeks before treatment to three weeks after treatment)
- Changes in CD71 cryopreserved(Cryopreserved cells are measured 6 months after sample collection)
- Changes in RNA cryopreserved(Cryopreserved cells are measured 6 months after sample collection)
- Changes in HbA1c(In the period from two weeks before treatment to three weeks after treatment)
- Changes in CD47 cryopreserved(Cryopreserved cells are measured 6 months after sample collection)
- Changes in CD59 cryopreserved(Cryopreserved cells are measured 6 months after sample collection)
- Changes in Complete Blood Count on Sysmex - cryopreserved(Cryopreserved cells are measured 6 months after sample collection)
- Changes in ALAS 2(Up to 5 years)
- Changes in SLC4a1(Up to 5 years)
- Changes in blood volume(Within 14 days before treatment and within 14 days after treatment)
- Changes in CD35 cryopreserved(Cryopreserved cells are measured 6 months after sample collection)
- Changes in CD55 cryopreserved(Cryopreserved cells are measured 6 months after sample collection)
- Changes in Complete Blood Count on Advia(In the period from two weeks before treatment to three weeks after treatment)
- Changes in Complete Blood Count on Advia - cryopreserved(Cryopreserved cells are measured 6 months after sample collection)
- Changes in Ferritin(In the period from two weeks before treatment to three weeks after treatment)
- Changes in Complete Blood Count on Sysmex(In the period from two weeks before treatment to three weeks after treatment)
- Changes in Band 3(Up to 5 years)
- Changes in FECH(Up to 5 years)
- Changes in CA1(Up to 5 years)
- Changes in CD71 in dried blood spots(Up to 5 years)