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

NCT07727356 | Active Not Recruiting DMC

• 1 other identifier: 2025-02217
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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: 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.

Conditions

Endocrine Disorders; Hypertension; Primary Aldosteronism; Cortisol Excess; Obesity & Overweight; Healthy Adult

Keywords

Endocrine Disorders; Wearable Devices; Digital Health; Chronoendocrinology; Blood Pressure Monitoring; Continuous Glucose Monitoring; Circadian Rhythm; Dynamic Hormone Sampling

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (13)

• Change in 24-Hour Diastolic Blood Pressure

  Day 6 to Day 13

• Change in Resting Heart Rate

  Day 6 to Day 13

• Change in Heart Rate Variability

  Day 6 to Day 13

• Change in Mean Interstitial Glucose Concentration

  Day 6 to Day 13

• Change in Percentage of Time in Target Glucose Range

  Day 6 to Day 13

Other Outcomes (1)

• Correlation Between Actigraphy-Derived Total Sleep Time and Diurnal Cortisol Rhythm

  27-hour U-RHYTHM sampling window at end of each phase

Study Arms (1)

Experimental: Sequential Home-Based Physiological Challenge

EXPERIMENTAL

Participants 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.

Behavioral: Sequential Dietary Sodium Modulation

Interventions

Sequential Dietary Sodium Modulation BEHAVIORAL

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.

Also known as: Mixed-Meal and Fasting Challenge, Short Exercise and Postural Challenge, Diagnostic dynamic test

Experimental: Sequential Home-Based Physiological Challenge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Felix Beuschlein: lead
• University Hospital, Zürich: collaborator
• University of Zurich: collaborator
• Pontificia Universidad Catolica de Chile: collaborator
• ETH Zurich (Switzerland): collaborator

Study Sites (1)

University Hospital Zürich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Endocrine System Diseases; Hypertension; Hyperaldosteronism; ACTH Syndrome, Ectopic; Obesity; Overweight

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Paraneoplastic Endocrine Syndromes; Paraneoplastic Syndromes; Neoplasms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Felix Beuschlein, Prof. Dr. med.

  University Hospital, Zürich

  STUDY CHAIR

• Thomas Uslar, MD; Assistant Professor

  Pontificia Universidad Católica de Chile, CETREN-UC / University Hospital Zürich

  STUDY DIRECTOR

• Felix Beuschlein, Prof. Dr. med.

  University Hospital, Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 27, 2026
• Study Start: July 3, 2026
• Primary Completion (Estimated): August 1, 2031
• Study Completion (Estimated): August 1, 2036
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning after publication of the study results and available for 5 years thereafter.
• Access Criteria: Requests for access to de-identified individual participant data should be directed to the sponsor-investigator (felix.beuschlein@usz.ch) and will be granted to qualified researchers with a methodologically sound proposal, subject to execution of a Data Use Agreement and approval by the study team.

Locations

CH (1)