Minimally-Invasive Realtime Assessment of Continuous Lactate in Exercise (MIRACLE)
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|ClinicalTrials.gov Identifier: NCT04238611|
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : August 26, 2021
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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.
|Condition or disease||Intervention/treatment||Phase|
|Exercise Lactate||Device: Microneedle Diagnostic Test: Blood lactate measurement Other: Exercise regimen||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Minimally-Invasive Realtime Assessment of Continuous Lactate in Exercise|
|Actual Study Start Date :||March 1, 2021|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||March 1, 2022|
Experimental: Lactate microneedle
Measurement of lactate through microneedle
Lactate microneedle applied on the skin of participant
Diagnostic Test: Blood lactate measurement
Serum lactate testing through conventional laboratory methods
Other: Exercise regimen
Standardised aerobic exercise regimen
- Performance of microneedle [ Time Frame: 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.
- Acceptability [ Time Frame: 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04238611
|Contact: Damien Ming||+44(0)firstname.lastname@example.org|
|Imperial College London||Recruiting|
|London, United Kingdom, W12 0HS|
|Contact: Alison H Holmes, MD MPH MBBS|
|Principal Investigator:||Alison H Holmes||Imperial College London|
|Responsible Party:||Imperial College London|
|Other Study ID Numbers:||
|First Posted:||January 23, 2020 Key Record Dates|
|Last Update Posted:||August 26, 2021|
|Last Verified:||August 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|