Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07727356

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersAccepted

ConditionEndocrine Disorders, Hypertension, Primary Aldosteronism, Cortisol Excess, Obesity & Overweight, Healthy Adult

Full registry criteria

Inclusion Criteria: 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 * Functional or non-functional neuroendocrine tumor * Osteoporosis * Lipid disorder * Thyroid disorder * Hypoparathyroidism or hyperparathyroidism * Inborn error of metabolism * People undergoing gender-affirming hormone therapy Exclusion Criteria: * 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

Treatments and study arms

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.

Primary outcomes

Change in 24-hour systolic blood pressureFrom Day 6 (end of low-sodium phase) to Day 13 (end of high-sodium phase)

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University Hospital Zürich🇨🇭 Zurich, Switzerland

Open map