Exercise, Lactate
Conditions
Keywords
Minimally-invasive, Microneedle
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.
Interventions
DEVICEMicroneedle
Lactate microneedle applied on the skin of participant
DIAGNOSTIC_TESTBlood lactate measurement
Serum lactate testing through conventional laboratory methods
OTHERExercise regimen
Standardised aerobic exercise regimen
Sponsors
Imperial College London
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Contacts
Primary ContactDamien Ming
Outcome results
None listed