ExerciseMIRACLENCT04238611
Minimally-Invasive Realtime Assessment of Continuous Lactate in Exercise
A study testing Microneedle, Blood lactate measurement and Exercise regimen in people with Exercise and Lactate, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Microneedle, Blood lactate measurement and Exercise regimen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2021to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College London
London, W12 0HS
Alison H Holmes, MD MPH MBBS
About this study
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.
Read the 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.
- Being tested
- Microneedle, Blood lactate measurement, Exercise regimen
- Keywords
- Minimally-invasive, Microneedle
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroneedleDevice
Lactate microneedle applied on the skin of participant
Blood lactate measurementDiagnostic test
Serum lactate testing through conventional laboratory methods
Exercise regimenOther
Standardised aerobic exercise regimen
| Study group | Role | What they receive |
|---|---|---|
| Lactate microneedle | Experimental | Measurement of lactate through microneedle Receives: Device: Microneedle; Diagnostic Test: Blood lactate measurement; Other: Exercise regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (1)
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 Mar 2021
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alison H Holmes, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238611
- Sponsor's protocol ID
- 19HH5646
- Acronym
- MIRACLE
- Status last verified
- Aug 2021
- First submitted
- 17 Jan 2020
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40979517
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally-Invasive Realtime Assessment of Continuous Lactate in Exercise
- ClinicalTrials.gov ID
- NCT04238611
- Acronym / sponsor ID
- MIRACLE / 19HH5646
- Keywords
- Minimally-invasive, Microneedle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lactate microneedle | Experimental | Device: Microneedle, Diagnostic Test: Blood lactate measurement, Other: Exercise regimenMeasurement of lactate through microneedle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroneedleLactate microneedle applied on the skin of participant | Device | Lactate microneedle |
| Blood lactate measurementSerum lactate testing through conventional laboratory methods | Diagnostic test | Lactate microneedle |
| Exercise regimenStandardised aerobic exercise regimen | Other | Lactate microneedle |
Primary outcome
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.
1 secondary outcome
Acceptability
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Derived from this study: PubMed 40979517Ming 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.
- Individual participant dataSharing planned: No
Related trials for Exercise
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alison H Holmes principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedle, Blood lactate measurement and Exercise regimen in people with Exercise and Lactate, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damien Ming (+44(0)20331132732, d.ming@ic.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of microneedle (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04238611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.