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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactate microneedle | Experimental | Measurement of lactate through microneedle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microneedle | Device | Lactate microneedle applied on the skin of participant |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Damien Ming | Contact | +44(0)20331132732 | d.ming@ic.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Alison H Holmes | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London | Recruiting | London | W12 0HS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40979517 | Derived | Ming DK, Jangam S, Gowers SA, Wilson R, Freeman DM, Boutelle MG, Cass AE, O'Hare D, Holmes AH. Real-time continuous measurement of lactate through a minimally invasive microneedle patch: a phase I clinical study. BMJ Innov. 2022 Apr;8(2):87-94. doi: 10.1136/bmjinnov-2021-000864. Epub 2022 Feb 28. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 24, 2022 | |
| Reset | Jul 19, 2022 | |
| Release | Feb 24, 2023 | |
| Reset | Dec 1, 2023 | |
| Release | Jul 22, 2024 | |
| Reset | Oct 11, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 24, 2022 | Jul 19, 2022 | |||
| Feb 24, 2023 |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Blood lactate measurement |
| Diagnostic Test |
Serum lactate testing through conventional laboratory methods |
|
| Exercise regimen | Other | Standardised aerobic exercise regimen |
|
| Dec 1, 2023 |
| Jul 22, 2024 | Oct 11, 2024 |