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Endocrine DisordersEndoSenseNCT07727356

EndoSense: Continuous Real-Time Monitoring of Health Markers in Endocrine and Metabolic Disorders

A study testing Sequential Dietary Sodium Modulation in people with Endocrine Disorders and Hypertension, run by Felix Beuschlein at 1 site in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this trial is to learn whether wearable devices and hormone sampling can measure how the body changes during daily-life challenges in adults with endocrine or metabolic disorders. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Sequential Dietary Sodium Modulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSwitzerland
Study dates
3 Jul 2026to Aug 2036
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Diagnosis or suspected diagnosis of at least one endocrine or metabolic disorder, including:
  • Overweight or obesity, defined as body mass index of 25 kg/m² or higher
  • Essential hypertension
  • Diabetes mellitus, including type 1 diabetes, type 2 diabetes, gestational diabetes, maturity-onset diabetes of the young, or unclassified diabetes
  • Hypoglycemia
  • Endogenous hypercortisolism
Show all 22Show fewer
  • Primary aldosteronism
  • Endogenous or exogenous adrenal insufficiency
  • Congenital adrenal hyperplasia
  • Polycystic ovary syndrome
  • Adrenocortical tumor or adrenal incidentaloma
  • Functional or non-functional pituitary tumor
  • Pituitary insufficiency
  • Polyuria-polydipsia syndrome
  • Hyponatremia
  • Functional or non-functional neuroendocrine tumor
  • Osteoporosis
  • Lipid disorder
  • Thyroid disorder
  • Hypoparathyroidism or hyperparathyroidism
  • Inborn error of metabolism
  • People undergoing gender-affirming hormone therapy

Who cannot join

  • Known or suspected severe skin disorder or allergy that may interfere with wearable sensor placement, such as extensive eczema, psoriasis, chronic ulcers, or severe tape intolerance
  • Known impaired wound healing or strong keloid tendency that would make repeated skin application or microneedle use unsuitable
  • Pregnancy or lactation, for participation in home monitoring or dynamic hormone sampling
  • Known or suspected bleeding disorder, such as von Willebrand disease
  • Current treatment with anticoagulant or antiplatelet therapy at a dose that increases bleeding risk
  • Severe acute or chronic medical condition that, in the investigator's opinion, would interfere with study procedures or compromise participant safety, such as decompensated heart failure, unstable angina, or acute systemic infection
Show all 11Show fewer
  • Current lithium treatment, because the intervention may alter lithium levels
  • Recent travel across more than 4 time zones within the past 14 days, if study endpoints rely on circadian hormone profiles
  • Ongoing shift work, if study endpoints rely on circadian hormone profiles
  • Inability to give informed consent
  • Inability to comply with study procedures

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • University Hospital Zürich

    Zurich, 8091

Other trials in Switzerland

About this study

The goal of this trial is to learn whether wearable devices and hormone sampling can measure how the body changes during daily-life challenges in adults with endocrine or metabolic disorders. These disorders include conditions such as high blood pressure, adrenal disorders, diabetes, obesity, thyroid disorders, pituitary disorders, and other hormone-related conditions.

The main questions it aims to answer are:

Read more

Can wearable devices measure changes in blood pressure, heart rate, sleep, activity, temperature, and glucose during changes in salt intake, meals, fasting, and short exercise? Do these changes differ between people with different endocrine or metabolic disorders? Are wearable devices acceptable and practical for participants to use at home?

There is no comparison group in this study. Each participant will serve as their own comparison by completing different study phases.

Participants will wear study devices at home to measure blood pressure, heart rate, activity, sleep, temperature, and glucose, follow a low-salt diet for about 1 week and then a high-salt diet for about 1 week, using study instructions, complete meal, fasting, and short exercise tasks, give urine and saliva samples, and possibly blood samples, during the study. Optionally wear a hormone sampling device for about 27 hours, complete short questionnaires about symptoms, sleep, physical activity, and their experience using the devices.

The study will help researchers understand whether wearable monitoring can support future diagnosis and care for people with endocrine and metabolic disorders.

Read the detailed description

EndoSense is a monocentric, single-arm, non-randomized, before-and-after interventional study conducted at the University Hospital Zurich within the European ENDOTRAIN consortium. The study is designed to evaluate whether continuous wearable monitoring, combined with dynamic hormone sampling, can capture meaningful physiological and endocrine responses during standardized environmental challenges in adults with endocrine or metabolic disorders.

Current diagnostic approaches in endocrinology often rely on single time-point measurements, although many endocrine and metabolic processes vary across the day and in response to salt intake, meals, fasting, sleep, and physical activity. EndoSense addresses this gap by combining home-based physiological monitoring with structured dietary and activity modules. The study will assess whether wearable-derived data can provide clinically relevant information on blood pressure, heart rate, heart rate variability, activity, sleep, temperature, and glucose patterns, and whether these data correspond to dynamic hormonal changes.

Each participant will complete a structured home-monitoring protocol. The protocol includes a baseline home-monitoring period followed by sequential dietary sodium modulation, starting with a low-sodium phase and followed by a high-sodium phase. Standardized mixed-meal, fasting, postural, and short exercise modules are included to characterize postprandial, fasting, hemodynamic, and stress-related physiological responses. These modules may be adapted or omitted according to the participant's underlying condition, safety considerations, and preferences after consultation with the study physician.

During the home-monitoring phase, participants will wear several study devices. These include devices for periodic blood pressure and pulse monitoring, continuous glucose monitoring, activity and movement assessment, sleep monitoring, and temperature monitoring. Data from these devices are collected for research purposes only and will not guide clinical care during the study. Participants will also complete brief electronic diaries and questionnaires to document adherence, symptoms, sleep, physical activity, usability, and acceptance of the study devices.

A subset of participants who provide separate consent will undergo dynamic hormone sampling using the U-RHYTHM system. This device collects subcutaneous interstitial fluid samples over approximately 27 hours and is used to study day-night and short-term hormone patterns. The hormone sampling module is optional and will be performed at selected time points during the protocol and, when appropriate, during routine clinical assessments.

After the home-based phase, participants will undergo a clinical integration phase during routine care at the Department of Endocrinology, Diabetology and Clinical Nutrition, University Hospital Zurich. Wearable data collected during routine diagnostic procedures will be compared with standard clinical assessments to explore how sensor-derived patterns relate to established endocrine and metabolic tests.

The study uses a within-participant design, meaning that each participant serves as their own reference across the different protocol phases. This design reduces between-person variability and allows the researchers to assess individual physiological responses to standardized changes in salt intake, meals, fasting, and short exercise. The study will also explore whether these responses differ across endocrine and metabolic conditions and whether biological sex influences physiological or hormonal patterns.

Safety measures are integrated throughout the protocol. Participants receive standardized instructions, predefined safety thresholds, and access to study physician contact if concerning symptoms or abnormal measurements occur. Potential risks include transient changes in blood pressure or glucose levels, discomfort related to dietary changes or exercise, and mild local reactions related to wearable devices or optional sampling procedures. Participation is voluntary, and participants may withdraw at any time without consequences for their clinical care.

The study aims to establish a sensor-integrated research framework for endocrine and metabolic disorders. In the long term, the knowledge generated by EndoSense may support the development of wearable-based monitoring environments as complementary tools for endocrine diagnostics, risk assessment, and personalized clinical care.

Being tested
Sequential Dietary Sodium Modulation
Keywords
Endocrine Disorders, Wearable Devices, Digital Health, Chronoendocrinology, Blood Pressure Monitoring, Continuous Glucose Monitoring, Circadian Rhythm, Dynamic Hormone Sampling
Medical subject headings
Endocrine System Diseases, Hypertension, Hyperaldosteronism, ACTH Syndrome, Ectopic, Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sequential Dietary Sodium ModulationBehavioural

    Also called Mixed-Meal and Fasting Challenge, Short Exercise and Postural Challenge, Diagnostic dynamic test

    Participants will complete a standardized home and clinic monitoring protocol using wearable devices. The protocol includes low- and high-sodium diet phases, meal and fasting modules, postural and short exercise challenges, and wearable monitoring during routine endocrine functional tests. The study will assess changes in blood pressure, heart rate, glucose, activity, sleep, temperature, and hormone patterns in response to these challenges.

Study groups in NCT07727356
Study groupRoleWhat they receive
Experimental: Sequential Home-Based Physiological ChallengeExperimentalParticipants will complete a single-arm, within-participant home-monitoring protocol. All participants will first undergo baseline monitoring, followed by sequential low-sodium and high-sodium diet phases and clinic-based phase. During these phases, participants will wear study devices to measure blood pressure, heart rate, heart rate variability, activity, sleep, temperature, and glucose. Mixed-meal, fasting, postural, and short exercise modules will be included when appropriate. Optional dynamic hormone sampling will be performed in participants who provide separate consent.
Receives: Behavioral: Sequential Dietary Sodium Modulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in 24-hour systolic blood pressure

    Change in mean 24-hour systolic blood pressure (mmHg), measured using a validated cuffless automated home blood pressure device, comparing the last 24 hours of the high-sodium diet phase to the last 24 hours of the low-sodium diet phase.

    Measured: From Day 6 (end of low-sodium phase) to Day 13 (end of high-sodium phase)

Secondary outcomes (13)
  1. Change in 24-Hour Diastolic Blood Pressure

    Change in mean 24-hour diastolic blood pressure (mmHg), measured via automated home blood pressure device.

    Measured: Day 6 to Day 13

  2. Change in Resting Heart Rate

    Change in mean resting heart rate (beats per minute), measured via wearable actimeter/ECG device.

    Measured: Day 6 to Day 13

  3. Change in Heart Rate Variability

    Change in heart rate variability (SDNN, milliseconds), measured via wearable ECG device.

    Measured: Day 6 to Day 13

  4. Change in Mean Interstitial Glucose Concentration

    Change in mean interstitial glucose concentration (mmol/L), measured via continuous glucose monitor.

    Measured: Day 6 to Day 13

  5. Change in Percentage of Time in Target Glucose Range

    Change in percentage of time with interstitial glucose within target range (%), measured via continuous glucose monitor.

    Measured: Day 6 to Day 13

  6. Change in Plasma Aldosterone Concentration

    Change in aldosterone concentration (pg/mL), measured in interstitial microdialysate via the U-RHYTHM sampling device and quantified by LC-MS/MS.

    Measured: Day 6 to Day 13

  7. Change in Plasma Renin Concentration

    Change in renin concentration (pg/mL), measured in interstitial microdialysate via the U-RHYTHM sampling device and quantified by ELISA.

    Measured: Day 6 to Day 13

  8. Change in Interstitial Cortisol Rhythm (Area Under the Curve)

    Change in cortisol area-under-the-curve (nmol/L×h) over the 27-hour sampling window, measured via U-RHYTHM interstitial microdialysis and quantified by LC-MS/MS.

    Measured: 27-hour U-RHYTHM sampling window at end of each phase (Day 6-7 vs. Day 13-14)

  9. 24-Hour Urinary Sodium Excretion

    Sodium excretion (mmol/24h) in a 24-hour urine collection, used to verify dietary sodium adherence.

    Measured: Day 7 and Day 14

  10. Change in EQ-5D Visual Analog Scale Score

    Change in self-rated overall health, measured using the EQ-5D Visual Analog Scale (units on a 0-100 scale).

    Measured: Day 1, Day 7 and Day 14

  11. Change in Pittsburgh Sleep Quality Index Global Score

    Change in sleep quality, measured using the Pittsburgh Sleep Quality Index (PSQI) global score (units on a 0-21 scale).

    Measured: Day 1, Day 7 and Day 14

  12. System Usability Scale Score

    Wearable device usability, measured using the System Usability Scale (SUS) (units on a 0-100 scale).

    Measured: Day 7 and Day 14

  13. International Physical Activity Questionnaire-Short Form Score

    Self-reported physical activity level, measured using the IPAQ-SF (MET-minutes/week).

    Measured: Day 1, Day 7 and Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2026
  2. Study start3 Jul 2026
  3. Primary completionAug 2031 (estimated)
  4. Study completionAug 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07727356
Sponsor's protocol ID
2025-02217
Other IDs
2025
Acronym
EndoSense
Status last verified
Jul 2026
First submitted
13 Jul 2026
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying published results, together with a data dictionary, will be shared via the University of Zurich repository ZORA. Access to more granular de-identified datasets may be granted upon reasonable request under a Data Use Agreement (DUA) that (i) prohibits re-identification, (ii) restricts use to the approved research purpose, and (iii) requires appropriate data-security safeguards. No directly identifying data will be shared.

Questions about this trial

What is this clinical trial studying?

A study testing Sequential Dietary Sodium Modulation in people with Endocrine Disorders and Hypertension, run by Felix Beuschlein at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 24-hour systolic blood pressure (time frame: From Day 6 (end of low-sodium phase) to Day 13 (end of high-sodium phase)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

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