NCT04238611

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

6 months

First QC Date

January 17, 2020

Last Update Submit

August 25, 2021

Conditions

ExerciseLactate

Keywords

Minimally-invasiveMicroneedle

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Acceptability

    2 hours

Study Arms (1)

Lactate microneedle

EXPERIMENTAL

Measurement of lactate through microneedle

Device: MicroneedleDiagnostic Test: Blood lactate measurementOther: Exercise regimen

Interventions

MicroneedleDEVICE

Lactate microneedle applied on the skin of participant

Lactate microneedle
Blood lactate measurementDIAGNOSTIC_TEST

Serum lactate testing through conventional laboratory methods

Lactate microneedle
Exercise regimenOTHER

Standardised aerobic exercise regimen

Lactate microneedle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London

London, W12 0HS, United Kingdom

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40979517DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Alison H Holmes

    Imperial College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Damien Ming

CONTACT

+44(0)20331132732d.ming@ic.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 23, 2020

Study Start

March 1, 2021

Primary Completion

September 1, 2021

Study Completion

March 1, 2022

Last Updated

August 26, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)