Doping in Sport, Glucocorticoids
Conditions
Keywords
glucocordicoids, Doping, sport, urinary
Brief summary
Intra-articular and peri-articular glucocorticoid (GC) injections are common in sports medicine. However, from 1st January 2022, all injectable GC routes (including intra-articular administration (IA)) will be prohibited in-competition by World Anti-Doping Agency (WADA). Due to these rules, an IA GC treatment out-of-competition could result in an adverse analytical finding (AAF) in-competition if the washout period is not clearly defined. The aim of this study is to determine the urinary excretion profile of triamcinolone acetonide following IA to help in the definition of the washout periods.
Interventions
DRUGknee intra-articular infiltration with Triamcinolone acetonide
knee intra-articular intra-articular ultrasound-guided infiltration of Triamcinolone acetonide
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sports practice at least 4h / week * No comorbidities against indicating intra-articular knee injection * Subject with a knee disease requiring intra-articular injection of GCs
Exclusion criteria
* Subject with glucocorticoid (GC) allergy or GC medical contraindication * Pregnant women or women of childbearing potential without effective contraception * Washout period of all injectable routes and systemic use of GCs less than 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of the excretion profile of triamcinolone acetonide in urine following intra-articular ultrasound-guided injection | Change from baseline, pre-injection (day 0) to date (up to 35 days) where glucocorticoids urinary value below the 15 ng/ml | For subjects with a glucocorticoids urinary value below the 15 ng/ml threshold at D0 (before injection), identification of the date (up to 35 days) following the intra-articular ultrasound-guided injection which will correspond in the standards of the World Agency (under 15 ng/ml) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determination of the excretion profile of cortisol in urine following intra-articular ultrasound-guided injection to evaluate systemic effect | Change from baseline, pre-injection (day 0) glucocorticoids urinary value up to 35 days | — |
| Determination of the excretion profile of triamcinolone acetonide in DBS anti-doping test following intra-articular ultrasound-guided injection. | Change from baseline, pre-injection (day 0) glucocorticoids DBS value up to 35 days | — |
| Modeling of the excretion profile of triamcinolone acetonide in DBS anti-doping test following intra-articular ultrasound-guided injection. | evolution glucocorticoids blood value from baseline, pre-injection (day 0) to Day 35 | Evolution of blood triamcinolone acetonide concentration |
| Modeling of the excretion profile of triamcinolone acetonide in urine following intra-articular ultrasound-guided injection. | evolution glucocorticoids urinary value from baseline, pre-injection (day 0) to Day 35 | Evolution of urinary triamcinolone acetonide concentration |
| Identification of GCs on hair mark presence one month after intra-articular ultrasound-guided injection of triamcinolone acetonide. | Change from baseline, pre-injection (day 0) glucocorticoids hair value up to 35 days | — |
| Evaluation of the impact of exogenous corticosteroids on endogenous steroids profile (androgens and GCs) in DBS samples. | Change from baseline, pre-injection (day 0) glucocorticoids DBS value up to 35 days | Mesure of blood exogenous corticosteroids on endogenous steroidsconcentration |
| Determination of cortisol levels in DBS to evaluate systemic effect | Change from baseline, pre-injection (day 0) glucocorticoids DBS value up to 35 days | — |
Countries
France
Outcome results
None listed