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

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).

Study Overview

• Status: Recruiting
• Conditions: Hyperaldosteronism; Cushing Syndrome; Adrenal Insufficiency
• Intervention / Treatment: 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)

• Study Type: Observational
• Enrollment (Estimated): 12

Contacts and Locations

• Study Contact: Name: Adelina Ameti; Phone Number: 0041795568630; Email: adelina.ameti@chuv.ch
• Study Contact Backup: Name: Nathalie Vionnet, MD-PhD; Email: nathalie.vionnet@chuv.ch

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1005
      • Recruiting
      • Centre Hospitalier Universitaire Vaudois (CHUV)
      • Contact: Emmanuelle Paccou; Phone Number: +41 79 556 60 13; Email: emmanuelle.paccou@chuv.ch
      • Principal Investigator: Nelly Pitteloud, M.D.
      • Contact: Adelina Ameti; Phone Number: +41 79 556 68 30; Email: adelina.ameti@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Healthy volunteers

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Healthy controls

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Nelly Pitteloud, MD, Centre Hospitalier Universitaire Vaudois

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: August 18, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Hyperaldosteronism; Cushing Syndrome; Adrenal Insufficiency
• Other Study ID Numbers: CER-VD : 2021-01674

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No