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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06008184
Acronym
SensoCort
Enrollment
12
Registered
2023-08-23
Start date
2021-09-01
Completion date
2024-08-31
Last updated
2023-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Insufficiency, Cushing Syndrome, Hyperaldosteronism

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

OTHER24 hours sampling of 4 biological fluids (blood, ISF, sweat and saliva)

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)

OTHER24 hours sampling of ISF or sweat (after validating the correlation with blood)

24 hours sampling in an ambulatory setting

Sponsors

Centre Hospitalier Universitaire Vaudois
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Cortisol levels in 4 biologicals fluids24 hoursComparison of cortisol levels in these 4 biological fluids

Secondary

MeasureTime frameDescription
Aldosterone levels in 4 biological fluids24 hoursComparison 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 hours24 hoursStudy 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 hours24 hoursStudy 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

Contacts

Primary ContactAdelina Ameti
adelina.ameti@chuv.ch0041795568630
Backup ContactNathalie Vionnet, MD-PhD
nathalie.vionnet@chuv.ch

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026