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| Name | Class |
|---|---|
| French Anti-Doping Agency (AFLD) | OTHER_GOV |
| University Hospital, Tours | OTHER |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical hydrocortisone administration | Active Comparator | dermal cream (twice a day, 2.5 g of cream, 1% hydrocortisone during 5 days) |
|
| Systemic hydrocortisone administration | Active Comparator | tablets (once a day, 50 mg, morning, during 50 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocortisone administration | Drug | Hydrocortisone administration with collection of blood, urine and saliva samples before (1 week), during (5 days) and after (1 week) the 2 treatments |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary concentration of cortisol and its metabolites with Gas Chromatography Mass Spectrometry | Gas Chromatography Mass Spectrometry to study biomarkers urine level at 8 am, 10 am, 8 pm | 7 days |
| Urinary concentration of cortisol and its metabolites with Gas Chromatography Mass Spectrometry | Gas Chromatography Mass Spectrometry to study biomarkers urine level at 8 am, | Day 12 |
| Urinary concentration of cortisol and its metabolites with Isotope ratio mass spectrometry t | Isotope ratio mass spectrometry to study biomarkers urine level at 8 am, 10 am, 8 pm | 7 days |
| Urinary concentration of cortisol and its metabolites with Isotope ratio mass spectrometry t | Isotope ratio mass spectrometry to study biomarkers urine level at 8 am | Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| blood concentration of cortisol | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm | 7 days |
| blood concentration of cortisol | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; |
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Inclusion Criteria:
male subjects
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
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| Name | Affiliation | Role |
|---|---|---|
| AMIOT Virgile, MD | Hospital Regional Center of ORLEANS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Hospital Center of ORLEANS | Orléans | 45067 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17805102 | Background | Arlettaz A, Portier H, Lecoq AM, Rieth N, De Ceaurriz J, Collomp K. Effects of short-term prednisolone intake during submaximal exercise. Med Sci Sports Exerc. 2007 Sep;39(9):1672-8. doi: 10.1249/mss.0b013e3180dc992c. | |
| 19056411 | Background | Buisson C, Mongongu C, Frelat C, Jean-Baptiste M, de Ceaurriz J. Isotope ratio mass spectrometry analysis of the oxidation products of the main and minor metabolites of hydrocortisone and cortisone for antidoping controls. Steroids. 2009 Mar;74(3):393-7. doi: 10.1016/j.steroids.2008.11.001. Epub 2008 Nov 13. |
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Monocentric, randomized, open-label study
Distribution of patients in groups according to a ratio (1:1)
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| Day 12 |
| blood concentration of DeHydroEpiAndrostérone | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm | 7 days |
| blood concentration of DeHydroEpiAndrostérone | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; | day 12 |
| blood concentration of Adreno CorticoTrophic Hormone | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm | 7 days |
| blood concentration of Adreno CorticoTrophic Hormone | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; | Day 12 |
| saliva concentration of cortisol | Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm | 7 days |
| saliva concentration of DeHydroEpiAndrostérone | Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm | 7 days |
| saliva concentration of Adreno CorticoTrophic Hormone | Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm | 7 days |
| saliva concentration of cortisol | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am | Day 12 |
| saliva concentration of Adreno CorticoTrophic Hormone | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am | Day 12 |
| saliva concentration of DeHydroEpiAndrostérone | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am | Day 12 |
| 27643452 | Background | Collomp K, Arlettaz A, Buisson C, Lecoq AM, Mongongu C. Glucocorticoid administration in athletes: Performance, metabolism and detection. Steroids. 2016 Nov;115:193-202. doi: 10.1016/j.steroids.2016.09.008. Epub 2016 Sep 16. |
| 18048433 | Background | Collomp K, Arlettaz A, Portier H, Lecoq AM, Le Panse B, Rieth N, De Ceaurriz J. Short-term glucocorticoid intake combined with intense training on performance and hormonal responses. Br J Sports Med. 2008 Dec;42(12):983-8. doi: 10.1136/bjsm.2007.043083. Epub 2007 Nov 29. |