Minimally-Invasive Realtime Assessment of Continuous Lactate in Exercise

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-03-01

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.

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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.

Conditions

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Exercise Lactate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Lactate microneedle

Measurement of lactate through microneedle

Group Type EXPERIMENTAL

Microneedle

Intervention Type DEVICE

Lactate microneedle applied on the skin of participant

Blood lactate measurement

Intervention Type DIAGNOSTIC_TEST

Serum lactate testing through conventional laboratory methods

Exercise regimen

Intervention Type OTHER

Standardised aerobic exercise regimen

Interventions

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Microneedle

Lactate microneedle applied on the skin of participant

Intervention Type DEVICE

Blood lactate measurement

Serum lactate testing through conventional laboratory methods

Intervention Type DIAGNOSTIC_TEST

Exercise regimen

Standardised aerobic exercise regimen

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Consenting adults ≥ 18 years old
2. Healthy with no other previous medical history
3. 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

1. Active inflammatory skin condition such as eczema or dermatitis
2. Active soft tissue infection or infection at any site
3. Known hypersensitivity to any microneedle component or dressings
4. Presence of any implantable electronic devices such as a pacemaker or stimulators

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes