Exosome Proteomics to Detect EPO
1 other identifier
interventional
72
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Sep 2019
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedStudy Start
First participant enrolled
September 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2020
CompletedSeptember 25, 2019
September 1, 2019
1.1 years
September 27, 2018
September 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood proteome enrichment pathway analysis in GO annotation
Change in enrichment (measured in blood and assessed using GO annotation)
At baseline and after week 3 of treatment
Secondary Outcomes (1)
Blood markers of iron
At baseline and after week 3 of treatment
Study Arms (3)
Placebo
PLACEBO COMPARATORSaline infusion
EPO
EXPERIMENTALErythropoetin infusion (9 IU/kg)
EPO II
EXPERIMENTALErythropoetin infusion (20 IU/kg)
Interventions
Eligibility Criteria
You may qualify if:
- VO2max of at least 55+/-2 for men and 50+/-2 for women
- BMI between 18 and 27
- Resting hematocrit of less than 46%
You may not qualify if:
- 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
- Smoker
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Morten Hostrup, PhDlead
- University of Tasmaniacollaborator
Study Sites (1)
August Krogh Building
Copenhagen, Denmark
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 27, 2018
First Posted
October 9, 2018
Study Start
September 4, 2019
Primary Completion
October 15, 2020
Study Completion
October 15, 2020
Last Updated
September 25, 2019
Record last verified: 2019-09