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

NCT06980753 | Not Yet Recruiting DMC

• 1 other identifier: Adrenal biossensor 01
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cushing Syndrome; Primary Aldosteronism; Adrenal Insufficiency

Keywords

Aldosterone; Cortisol; Biossensor; Interstitial fluid; Adrenal insuficiency; Cushing syndrome

Outcome Measures

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

  8 weeks

Study Arms (1)

Interstitial fluid collection and biossensor use

EXPERIMENTAL

Device: Participants will use the biossensor for 48 h

Interventions

Participants will use the biossensor for 48 h DEVICE

Participants will use the biossensor for 48 h

Interstitial fluid collection and biossensor use

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Swiss Federal Institute of Technology in Zurich (ETH Zurich): collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

University of São Paulo - General Hospital

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Cushing Syndrome; Hyperaldosteronism; Adrenal Insufficiency

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 20, 2025
• Study Start: June 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)