Continuous Steroid Monitoring in Interstitial Fluid With Wearable and Nanoparticle-enhanced Biosensors for Improved Management of Adrenal Disorders

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo General Hospital

About this trial

The goal of this project is to provide novel technology that will pave the way from the present single-point (analogue) endocrinology towards continuous cortisol and aldosterone monitoring with full time resolution. Current endocrine practice relies on occasional and often random determination of hormone level or functional tests that require a clinical setting. These measurements include sample extraction and analysis in a clinical laboratory rendering such tests laborious and expensive. Most importantly, through the individual variations of hormone oscillation and spatiotemporal distribution of hormones, infrequent hormone measurements have limited diagnostic and prognostic value as the dynamic changes are not captured and relevant intra-individual variability occurs. A requirement for this vision are sensing solutions capable to track hormone dynamics over prolonged periods at high patient comfort (e.g., at home), as targeted by this research proposal. This project has the overarching goals of (1) establishing dynamic interstitial aldosterone and cortisol monitoring as reliable diagnostic tool for cortisol and aldosterone excess or deficiency, and (2) develop a wearable molecular sensing device to detect them accurately.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Individuals (males and females) older than 18 years;

Patients with primary adrenal insuffiency (cortisol and aldosterone deficiency);

Patients with Cushing Syndrome (cortisol excess)

Patients with Primary Aldosteronism (aldosterone excess)

Disqualifiers

Use of estrogen-containing oral contraceptive medication within the past 6 weeks;

Pregnancy or lactation;

Use of oral, inhaled, parenteral, or topical glucocorticoids within the past 30 days.

Trial design

Design model

Single group

Treatments tested in this trial

  • Participants will use the biossensor for 48 h

    Device

    Participants will use the biossensor for 48 h

Treatment groups

246 Participants
are divided into 1 treatment group
Group A: Interstitial fluid collection and biossensor useExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The total area under the curve (AUC) of aldosterone and cortisol levels measured over 48 hours using the biossensor

It is important to note that the units of concentration for aldosterone (ng/dl) and cortisol (mcg/dl) do not influence the calculation of the AUC

Time frame
8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of Sao Paulo General Hospital

Lead sponsor

Swiss Federal Institute of Technology in Zurich (ETH Zurich)

Collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

Collaborator

This trial is not recruiting at the moment. You can still explore other options: