Exosome Proteomics to Detect EPO

Morten Hostrup, PhD

Status: Unknown

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Erythropoietin

Study type: Interventional

Funder types: Other

Identifiers

NCT03700515

EPO-EXO

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Saline infusion

Treatment:

Drug: Placebo

EPO

Experimental group

Description:

Erythropoetin infusion (9 IU/kg)

Treatment:

Drug: Erythropoietin

EPO II

Experimental group

Description:

Erythropoetin infusion (20 IU/kg)

Treatment:

Drug: Erythropoietin