Administration of Hydrocortisone in Young Healthy Male Volunteers (H-CORT)

Administration of Hydrocortisone in Young Healthy Male Volunteers: Determination of Biomarkers for Distinguishing Between Local and Systemic Pathways

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.

Study Overview

• Status: Completed
• Conditions: Anti-doping Campaign, Detection of Hydrocortisone
• Intervention / Treatment: Drug: Hydrocortisone administration

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)

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Orleans, France, 45067
    • Regional Hospital center of ORLEANS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 26 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Topical hydrocortisone administration; dermal cream (twice a day, 2.5 g of cream, 1% hydrocortisone during 5 days)	Drug: Hydrocortisone administration; Hydrocortisone administration with collection of blood, urine and saliva samples before (1 week), during (5 days) and after (1 week) the 2 treatments
Active Comparator: Systemic hydrocortisone administration; tablets (once a day, 50 mg, morning, during 50 days)	Drug: Hydrocortisone administration; Hydrocortisone administration with collection of blood, urine and saliva samples before (1 week), during (5 days) and after (1 week) the 2 treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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;	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans
• Collaborators: University Hospital, Tours; French Anti-Doping Agency (AFLD)
• Investigators: Study Director: AMIOT Virgile, MD, Hospital Regional Center of ORLEANS

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2019
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (Actual): October 24, 2019

Study Record Updates

• Last Update Posted (Actual): December 7, 2020
• Last Update Submitted That Met QC Criteria: December 4, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: biomarkers; Hydrocortisone (cortisol); local administration of cortisol; systemic administration of cortisol
• Additional Relevant MeSH Terms: Anti-Inflammatory Agents; Hydrocortisone
• Other Study ID Numbers: CHRO 2019-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No