Anti-doping Campaign, Detection of Hydrocortisone
Conditions
Keywords
Hydrocortisone (cortisol), local administration of cortisol, systemic administration of cortisol, biomarkers
Brief summary
The misuse of cortisone or hydrocortisone for doping purpose in sport has been widely reported in the literature, but to date, no formal testing procedure is available and applicable in an anti-doping laboratory to detect hydrocortisone doping abuse , i.e., administration by systemic way. The investigators therefore propose to identify biomarkers that clearly distinguish between an authorized local administration of hydrocortisone and a prohibited systemic administration, by studying the impact of 5-day administration of hydrocortisone per 2 different routes.
Detailed description
Clinical research with two groups of ten volunteers one group with 5 days with local administration (cream, applied to healthy skin) one group with 5 days with systemic route of administration (per os)
Interventions
Hydrocortisone administration with collection of blood, urine and saliva samples before (1 week), during (5 days) and after (1 week) the 2 treatments
Sponsors
French Anti-Doping Agency (AFLD)
University Hospital, Tours
Centre Hospitalier Régional d'Orléans
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Monocentric, randomized, open-label study Distribution of patients in groups according to a ratio (1:1)
Eligibility
Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* male subjects * aged 18 to 30 years * 18 \< BMI \< 28 * participating in regular physical activity (3-5 times/week) * subjects not on medication
Exclusion criteria
asthmatic subjects or history of respiratory or cardiac pathology; use of corticosteroids in the past 6 months; high blood pressure; ulcerated lesions of the skin, acne, rosacea; Infectious state (bacterial, viral, and fungal infections); diabetic subjects; ulcerative history and other gastrointestinal disorders; lactose allergy; galactose intolerance; ulcerative colonic pathology; myastenia gravis; live vaccine kidney failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary concentration of cortisol and its metabolites with Gas Chromatography Mass Spectrometry | 7 days | Gas Chromatography Mass Spectrometry to study biomarkers urine level at 8 am, 10 am, 8 pm |
| Urinary concentration of cortisol and its metabolites with Isotope ratio mass spectrometry t | 7 days | Isotope ratio mass spectrometry to study biomarkers urine level at 8 am, 10 am, 8 pm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood concentration of Adreno CorticoTrophic Hormone | 7 days | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm |
| saliva concentration of cortisol | 7 days | Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm |
| blood concentration of cortisol | 7 days | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm |
| saliva concentration of Adreno CorticoTrophic Hormone | 7 days | Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm |
| saliva concentration of DeHydroEpiAndrostérone | 7 days | Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm |
| blood concentration of DeHydroEpiAndrostérone | 7 days | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm |
Countries
France
Outcome results
None listed