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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06008184
Other study ID # CER-VD : 2021-01674
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date August 31, 2024

Study information

Verified date September 2023
Source Centre Hospitalier Universitaire Vaudois
Contact Adelina Ameti
Phone 0041795568630
Email adelina.ameti@chuv.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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

Study Design


Intervention

Other:
24 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)
24 hours sampling of ISF or sweat (after validating the correlation with blood)
24 hours sampling in an ambulatory setting

Locations

Country Name City State
Switzerland Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne Vaud

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cortisol levels in 4 biologicals fluids Comparison of cortisol levels in these 4 biological fluids 24 hours
Secondary Aldosterone levels in 4 biological fluids Comparison of aldosterone levels in these 4 biological fluids 24 hours
Secondary 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
Secondary 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
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