Minimally-Invasive Realtime Assessment of Continuous Lactate in Exercise

Study Overview
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Brief Summary
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Lactate is a compound produced as a by-product of glycolysis. The increase in lactate concentration can result from a variety of causes, such as during anaerobic metabolism in exercise or haemodynamic shock in conditions such as sepsis. The study will aim to validate a novel microneedle-based minimally invasive device for the continuous measurement of lactate during exercise.

Detailed Description
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Lactate is a compound produced as a by-product of glycolysis. The increase in lactate concentration can result from a variety of causes, such as during anaerobic metabolism in exercise. The measurement of blood lactate during exercise has been routinely used to determine individual anaerobic thresholds, and optimise training in athletes. The measurement of the lactate trend requires multiple blood tests, and this can be uncomfortable. The need for repeated procedures may therefore restrict the full utility of the biomarker. Although point-of-care lactate measurements are possible, the barriers to initiating testing may also limit its role in clinical decision-making. The aim of the study is the validation of the microneedle-based lactate biosensor for real-time continuous lactate measurement in healthy volunteers during exercise as proof-of-concept.

Official Title
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Minimally-Invasive Realtime Assessment of Continuous Lactate in Exercise

Conditions
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Exercise, Lactate

Intervention / Treatment
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* Device: Microneedle
* Diagnostic Test: Blood lactate measurement
* Other: Exercise regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consenting adults ≥ 18 years old Healthy with no other previous medical history Able to perform moderately intensive exercise without difficulty for at least 30 minutes continuously, and engages in regular aerobic exercise at least twice a week Exclusion Criteria: Active inflammatory skin condition such as eczema or dermatitis Active soft tissue infection or infection at any site Known hypersensitivity to any microneedle component or dressings Presence of any implantable electronic devices such as a pacemaker or stimulators

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactate microneedle<br>Measurement of lactate through microneedle | Device: Microneedle<br>* Lactate microneedle applied on the skin of participant<br>Diagnostic Test: Blood lactate measurement<br>* Serum lactate testing through conventional laboratory methods<br>Other: Exercise regimen<br>* Standardised aerobic exercise regimen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of microneedle | Precision and accuracy of the lactate microneedle with reference to venous lactate as a gold standard. Current output from microneedle will be analysed against venous lactate and microdialysis lactate concentrations taken from participants every 5 minutes and concordance assessed through Bland-Altman analyses. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | Participant acceptability of the biosensor through an end-of-study questionnaire in terms of pain, comfort, physical restriction and skin sensation using a visual analogue scale between 0 to 10 cm, where increased discomfort is represented by a higher score. | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimally-invasive, Microneedle