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

Recruiting

• Conditions: Adrenal Insufficiency; Hyperaldosteronism; Cushing Syndrome
• Interventions: 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)

• Registration Number: NCT06008184
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2023-08-18
• Study First Submitted QC: 2023-08-18
• Study First Posted: 2023-08-23
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-06
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	24 hours sampling of ISF or sweat (after validating the correlation with blood)	-
Healthy controls	24 hours sampling of 4 biological fluids (blood, ISF, sweat and saliva)	-

Primary Outcome Measures

Name	Time	Method
Cortisol levels in 4 biologicals fluids	24 hours	Comparison of cortisol levels in these 4 biological fluids

Secondary Outcome Measures

Name	Time	Method
Aldosterone levels in 4 biological fluids	24 hours	Comparison of aldosterone levels in these 4 biological fluids
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
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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois (CHUV); 🇨🇭 Lausanne, Vaud, Switzerland