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Minimally-Invasive Realtime Assessment of Continuous Lactate in Exercise (MIRACLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04238611
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : August 26, 2021
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Description
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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.


Condition or disease Intervention/treatment Phase
Exercise Lactate Device: Microneedle Diagnostic Test: Blood lactate measurement Other: Exercise regimen Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Lactate microneedle
Measurement of lactate through microneedle
 Device: 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Damien Ming +44(0)20331132732 d.ming@ic.ac.uk

Locations
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United Kingdom
Imperial College London Recruiting
London, United Kingdom, W12 0HS
Contact: Alison H Holmes, MD MPH MBBS         
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Alison H Holmes Imperial College London
More Information
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04238611    
Other Study ID Numbers: 19HH5646
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Minimally-invasive
Microneedle