Minimally-Invasive Realtime Assessment of Continuous Lactate in Exercise

Not Applicable

• Conditions: Exercise; Lactate
• Interventions: Device: Microneedle; Diagnostic Test: Blood lactate measurement; Other: Exercise regimen

• Registration Number: NCT04238611
• Lead Sponsor: Imperial College London

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-23
• Study Start: 2021-03-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-26
• Primary Completion: 2021-09-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lactate microneedle	Microneedle	Measurement of lactate through microneedle
Lactate microneedle	Blood lactate measurement	Measurement of lactate through microneedle
Lactate microneedle	Exercise regimen	Measurement of lactate through microneedle

Primary Outcome Measures

Name	Time	Method
Performance of microneedle	30 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Acceptability	2 hours	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.

Trial Locations

Locations (1)

Imperial College London; 🇬🇧 London, United Kingdom