Anti-doping Campaign, Detection of Hydrocortisone Clinical Trial
— H-CORTOfficial title:
Administration of Hydrocortisone in Young Healthy Male Volunteers: Determination of Biomarkers for Distinguishing Between Local and Systemic Pathways
| Verified date | December 2020 |
| Source | Centre Hospitalier Régional d'Orléans |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 21 |
| Est. completion date | January 31, 2020 |
| Est. primary completion date | January 31, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 18 Years to 30 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Regional Hospital Center of ORLEANS | Orleans |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Régional d'Orléans | French Anti-Doping Agency (AFLD), University Hospital, Tours |
France,
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. Epub 2007 Nov 29. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Secondary | blood concentration of cortisol | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm | 7 days | |
| Secondary | blood concentration of cortisol | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; | Day 12 | |
| Secondary | blood concentration of DeHydroEpiAndrostérone | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; 10 am, 8 pm | 7 days | |
| Secondary | blood concentration of DeHydroEpiAndrostérone | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; | day 12 | |
| Secondary | 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 | |
| Secondary | blood concentration of Adreno CorticoTrophic Hormone | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am; | Day 12 | |
| Secondary | saliva concentration of cortisol | Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm | 7 days | |
| Secondary | saliva concentration of DeHydroEpiAndrostérone | Elisa test (enzyme-linked immunosorbent assay, ) to study cortisol concentration at 8 am; 10 am, 8 pm | 7 days | |
| Secondary | 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 | |
| Secondary | saliva concentration of cortisol | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am | Day 12 | |
| Secondary | saliva concentration of Adreno CorticoTrophic Hormone | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am | Day 12 | |
| Secondary | saliva concentration of DeHydroEpiAndrostérone | Elisa test (enzyme-linked immunosorbent assay) to study cortisol concentration at 8 am | Day 12 |