Clinical trial NCT04137302: Administration of Hydrocortisone in Young Healthy Male Volunteers
Official title: Administration of Hydrocortisone in Young Healthy Male Volunteers: Determination of Biomarkers for Distinguishing Between Local and Systemic Pathways
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anti-doping Campaign, Detection of Hydrocortisone
Keywords: Hydrocortisone (cortisol)
local administration of cortisol
systemic administration of cortisol
biomarkers
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
Collaborators: name: French Anti-Doping Agency (AFLD)
name: University Hospital, Tours
First posted: 2019-10-24
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Monocentric, randomized, open-label study

Distribution of patients in groups according to a ratio (1:1)
Primary purpose: OTHER

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)

Eligibility criteria: 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

Primary outcomes:
measure: Urinary concentration of cortisol and its metabolites with Gas Chromatography Mass Spectrometry
timeFrame: 7 days
measure: Urinary concentration of cortisol and its metabolites with Gas Chromatography Mass Spectrometry
timeFrame: Day 12
measure: Urinary concentration of cortisol and its metabolites with Isotope ratio mass spectrometry t
timeFrame: 7 days
measure: Urinary concentration of cortisol and its metabolites with Isotope ratio mass spectrometry t
timeFrame: Day 12
Secondary outcomes:
measure: blood concentration of cortisol
timeFrame: 7 days
measure: blood concentration of cortisol
timeFrame: Day 12
measure: blood concentration of DeHydroEpiAndrostérone
timeFrame: 7 days
measure: blood concentration of DeHydroEpiAndrostérone
timeFrame: day 12
measure: blood concentration of Adreno CorticoTrophic Hormone
timeFrame: 7 days
measure: blood concentration of Adreno CorticoTrophic Hormone
timeFrame: Day 12
measure: saliva concentration of cortisol
timeFrame: 7 days
measure: saliva concentration of DeHydroEpiAndrostérone
timeFrame: 7 days
measure: saliva concentration of Adreno CorticoTrophic Hormone
timeFrame: 7 days
measure: saliva concentration of cortisol
timeFrame: Day 12
measure: saliva concentration of Adreno CorticoTrophic Hormone
timeFrame: Day 12
measure: saliva concentration of DeHydroEpiAndrostérone
timeFrame: Day 12
Other outcomes:
Locations:
city: Orleans
country: France
facility: Regional Hospital Center of ORLEANS
Study officials:
affiliation: Hospital Regional Center of ORLEANS
name: AMIOT Virgile, MD
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.
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. doi: 10.1136/bjsm.2007.043083. Epub 2007 Nov 29.