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

NCT ID: NCT06008184

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2024-08-31

Brief Summary

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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

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Conditions

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Adrenal Insufficiency Cushing Syndrome Hyperaldosteronism

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy controls

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

Intervention Type OTHER

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)

Intervention Type OTHER

24 hours sampling in an ambulatory setting

Interventions

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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)

Intervention Type OTHER

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

24 hours sampling in an ambulatory setting

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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Nelly Pitteloud

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nelly Pitteloud, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Locations

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Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Adelina Ameti

Role: CONTACT

0041795568630

Nathalie Vionnet, MD-PhD

Role: CONTACT

Facility Contacts

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Adelina Ameti

Role: primary

+41 79 556 68 30

Emmanuelle Paccou

Role: backup

+41 79 556 60 13

Other Identifiers

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CER-VD : 2021-01674

Identifier Type: -

Identifier Source: org_study_id

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