Tracing Changed Production of Red Blood Cells
- Conditions
- Erythropoiesis AbnormalErythrocytosis
- Interventions
- Registration Number
- NCT05833477
- Lead Sponsor
- University of Copenhagen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment group Recombinant human erythropoietin Recombinant human erythropoietin treatment three times per week for three weeks
- Primary Outcome Measures
Name Time Method Changes in CD59 expression 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 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 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 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 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 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 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
- Secondary Outcome Measures
Name Time Method Changes in Mean Cell Volume cryopreserved Cryopreserved cells are measured 6 months after sample collection Mean Cell Volume distribution of red blood cells before and after cryopreservation
Continous blood glucose levels In the period from two weeks before treatment to three weeks after treatment Continuous blood glucose level throughout the study
Changes in CD71 cryopreserved Cryopreserved cells are measured 6 months after sample collection CD71 expression on red blood cells before and after cryopreservation
Changes in RNA cryopreserved Cryopreserved cells are measured 6 months after sample collection RNA expression inred blood cells before and after cryopreservation
Changes in HbA1c In the period from two weeks before treatment to three weeks after treatment Treatment induced changes in HbA1c content of red blood cells
Changes in CD47 cryopreserved Cryopreserved cells are measured 6 months after sample collection CD47 expression on red blood cells before and after cryopreservation
Changes in CD59 cryopreserved Cryopreserved cells are measured 6 months after sample collection CD59 expression on red blood cells before and after cryopreservation
Changes in Complete Blood Count on Sysmex - cryopreserved Cryopreserved cells are measured 6 months after sample collection Complete Blood Count analysis on the Sysmex XN-450 instrument before and after cryopreservation
Changes in ALAS 2 Up to 5 years Quantification of ALAS 2 in dried blood spots stored at room temperature, -20C and -80C
Changes in SLC4a1 Up to 5 years Quantification of SLC4a1 in dried blood spots
Changes in blood volume Within 14 days before treatment and within 14 days after treatment Measurement of blood volume by CO rebreathing
Changes in CD35 cryopreserved Cryopreserved cells are measured 6 months after sample collection CD35 expression on red blood cells before and after cryopreservation
Changes in CD55 cryopreserved Cryopreserved cells are measured 6 months after sample collection CD55 expression on red blood cells before and after cryopreservation
Changes in Complete Blood Count on Advia In the period from two weeks before treatment to three weeks after treatment Complete Blood Count analysis on the Advia 2120i instrument
Changes in Complete Blood Count on Advia - cryopreserved Cryopreserved cells are measured 6 months after sample collection Complete Blood Count analysis on the Advia 2120i instrument before and after cryopreservation
Changes in Ferritin In the period from two weeks before treatment to three weeks after treatment Quantification of plasma ferritin concentration
Changes in Complete Blood Count on Sysmex In the period from two weeks before treatment to three weeks after treatment Complete Blood Count analysis on the Sysmex XN-450 instrument
Changes in Band 3 Up to 5 years Quantification of Band 3 in dried blood spots
Changes in FECH Up to 5 years Quantification of FECH in dried blood spots
Changes in CA1 Up to 5 years Quantification of CA1 in dried blood spots
Changes in CD71 in dried blood spots Up to 5 years Quantification of CD71 in dried blood spots
Trial Locations
- Locations (1)
Department of Nutrition, Exercise and Sports
š©š°Copenhagen, Denmark