Minimally-Invasive Realtime Assessment of Continuous Lactate in Exercise

Exercise Clinical Trial

— MIRACLE  

Official title:

Minimally-Invasive Realtime Assessment of Continuous Lactate in Exercise

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04238611
• Other study ID #: 19HH5646
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: August 2021
• Source: Imperial College London
• Contact: Damien Ming
• Phone: +44(0)20331132732
• Email: d.ming[@]ic.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

The study will aim to validate a novel microneedle-based minimally invasive device for the continuous measurement of lactate during exercise.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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