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

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.

Study Overview

• Status: Recruiting
• Conditions: Exercise; Lactate
• Intervention / Treatment: Device: Microneedle; Diagnostic test: Blood lactate measurement; Other: Exercise regimen

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
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Damien Ming; Phone Number: +44(0)20331132732; Email: d.ming@ic.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, W12 0HS
    • Recruiting
    • Imperial College London
    • Contact: Alison H Holmes, MD MPH MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Alison H Holmes, Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: January 17, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Minimally-invasive; Microneedle
• Other Study ID Numbers: 19HH5646

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No