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

Adrenal Insufficiency Clinical Trial

— SensoCort  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06008184
• Other study ID #: CER-VD : 2021-01674
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Adrenal Insufficiency
• Cushing Syndrome
• Hyperaldosteronism

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