Real-time Monitoring of Cortisol - Comparison of Cortisol Levels in Four Biological Fluids

Study Overview
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Brief Summary
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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).

Official Title
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Real-time Monitoring of Cortisol - Comparison of Cortisol Levels in Four Biological Fluids

Conditions
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Adrenal Insufficiency, Cushing Syndrome, Hyperaldosteronism

Intervention / Treatment
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* Other: 24 hours sampling of 4 biological fluids (blood, ISF, sweat and saliva)
* Other: 24 hours sampling of ISF or sweat (after validating the correlation with blood)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy controls<br> | Other: 24 hours sampling of 4 biological fluids (blood, ISF, sweat and saliva)<br>* 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)<br>Other: 24 hours sampling of ISF or sweat (after validating the correlation with blood)<br>* 24 hours sampling in an ambulatory setting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cortisol levels in 4 biologicals fluids | Comparison of cortisol levels in these 4 biological fluids | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aldosterone levels in 4 biological fluids | Comparison of aldosterone levels in these 4 biological fluids | 24 hours | 
| Glucocorticoid - comparison of repeated measures of glucocorticoid concentrations (cortisol, 18OHF, cortisone) profiles - over a period of 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 | 24 hours | 
| Mineralocorticoid - comparison of repeated measures of aldosterone concentrations profiles - over a period of 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 | 24 hours |