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

• ClinicalTrials.gov Identifier: NCT04238611
• Recruitment Status: Recruiting
• First Posted: January 23, 2020
• Last Update Posted: August 26, 2021
• Sponsor: Imperial College London
• Information provided by (Responsible Party): Imperial College London

Tracking Information

• First Submitted Date: January 17, 2020
• First Posted Date: January 23, 2020
• Last Update Posted Date: August 26, 2021
• Actual Study Start Date: March 1, 2021
• Estimated Primary Completion Date: September 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 22, 2020)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 22, 2020)

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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Minimally-Invasive Realtime Assessment of Continuous Lactate in Exercise
• Official Title: Minimally-Invasive Realtime Assessment of Continuous Lactate in Exercise

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Device Feasibility

Condition

• Exercise
• Lactate

Intervention

• 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

Study Arms

Experimental: Lactate microneedle

Measurement of lactate through microneedle

Interventions:

• Device: Microneedle
• Diagnostic Test: Blood lactate measurement
• Other: Exercise regimen

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 22, 2020): 15
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 1, 2022
• Estimated Primary Completion Date: September 1, 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT04238611
• Other Study ID Numbers: 19HH5646
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Imperial College London
• Original Responsible Party: Same as current
• Current Study Sponsor: Imperial College London
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Alison H Holmes; Imperial College London

• PRS Account: Imperial College London
• Verification Date: August 2021