Adrenal Insufficiency, Cushing Syndrome, Hyperaldosteronism
Conditions
Brief summary
Cortisol is an essential for life hormone secreted in a pulsatile pattern on a diurnal rhythm. Given the complexity of cortisol secretion on a circadian rhythm with pulsations, current methods of cortisol measurement have limitations. Therefore, a non-invasive and ambulatory method would be useful to measure cortisol levels in real-time. The main aim of the study is to compare cortisol levels across biological fluids (sweat, saliva, interstitial fluid, and blood) in order to validate in the long term a continuous and non-invasive cortisol measurement device (currently under development).
Interventions
24 hours sampling of 4 biological fluids: * blood: sampling every 20 minutes (through a venous catheter) * ISF: automated sampling every 20 minutes (microdialysis technique connected to U-Rhythm device) * Sweat : collection of 1 to 3 samples at 4 differents timepoints * Saliva : sampling every hour (except during the night)
24 hours sampling in an ambulatory setting
Sponsors
Study design
Eligibility
Inclusion criteria
Healthy controls: Inclusion Criteria: * age between 18 and 30 years old * normal BMI 18 to 25 kg/m2 * weight stability
Exclusion criteria
* pregnancy, breastfeeding, irregular menses * any medical treatment * any medical issues * pilocarpine allergy, or latex allergy * glaucoma or acute irritis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cortisol levels in 4 biologicals fluids | 24 hours | Comparison of cortisol levels in these 4 biological fluids |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aldosterone levels in 4 biological fluids | 24 hours | Comparison of aldosterone levels in these 4 biological fluids |
| Glucocorticoid - comparison of repeated measures of glucocorticoid concentrations (cortisol, 18OHF, cortisone) profiles - over a period of 24 hours | 24 hours | Study of the diurnal rhythm and pulsatility in healthy participants (and later patients) * Diurnal rhythm: cosinor analysis. Comparison of nadir/acme of cortisol concentrations (and 18OHF, cortisone) among participants. Amplitude of the curve * Pulsatility analysis: frequency of the pulses and amplitude |
| Mineralocorticoid - comparison of repeated measures of aldosterone concentrations profiles - over a period of 24 hours | 24 hours | Study of the diurnal rhythm and pulsatility in healthy participants (and later patients) * Diurnal rhythm: cosinor analysis. Comparison of nadir/acme of aldosterone concentrations among participants. Amplitude of the curve * Pulsatility analysis: frequency of the pulses and amplitude |
Countries
Switzerland