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Pilot Testing a Novel Non-invasive Lactate Sensor

Primary Purpose

Hyperlactatemia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lactate sensor (Lactisense)
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Hyperlactatemia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy and physically active volunteers Exclusion Criteria: Existing health conditions e.g blood pressure > 150/95, joint injury that would contraindicate exercise. Individuals who answer "yes" to any of the health condition questions on the PAR-Q questionnaire will also be excluded. As ketones might interfere with the sensor signal, we will exclude anyone with metabolic conditions or following a ketogenic diet.

Sites / Locations

  • Alberta Diabetes Institute, University of Alberta

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Evaluation of non-invasive lactate sensor

Arm Description

To determine the efficacy and accuracy of the non-invasive lactate sensor

Outcomes

Primary Outcome Measures

That the lactate sensor under test is able track increase in interstitial lactate levels in exercising humans that follow the same time course as lactate values obtained from a commercial blood capillary lactate monitor.
The novel sensor data will be compared to lactate values measured simultaneously with a commercial blood capillary lactate monitor in exercising humans.

Secondary Outcome Measures

Full Information

First Posted
August 18, 2022
Last Updated
October 3, 2023
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT05649358
Brief Title
Pilot Testing a Novel Non-invasive Lactate Sensor
Official Title
Pilot Testing a Novel Non-invasive Lactate Sensor Using Split Ring Low Energy Microwave Sensors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 5, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
September 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To test the efficacy and accuracy of a novel non-invasive lactate sensor in humans undergoing strenuous leg exercise.
Detailed Description
The study investigators have designed a novel non-invasive lactate sensor (Lactisense) Lactisense is a planar, flexible, passive, chip-less resonator that can be taped to the skin in order to measure lactate levels in the body. It sends a signal to a nearby reader, which can be translated into a concentration value. It has so far been tested in the lab with good accuracy, but has not been tested on humans. The sensors are designed to use very low energy microwaves that can detect alterations in interstitial and muscle metabolites. In this study the investigators will test the sensor by having participants perform strenuous exercise (lifting weights) with Lactisense sensors attached to their skin on the top of the thigh and upper arm to evaluate lactate levels at the site of production and systemic levels respectively. The exercise will be performed using a well-established protocol to elevate lactate levels using a leg-press weights machine. The investigators will use a commercial capillary blood lactate meter (via finger prick) to verify whether lactate levels are actually changing in the body, and use Lactisense to try to measure these changes and compare to the values obtained using the commercial capillary blood lactate meter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlactatemia

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The investigators will test the device on 8 male and 8 female participants to determine if there are any sex differences in the performance of the sensor. As there is likely going to be inter-individual variability in the participants, the investigators have chosen to test 8 males and 8 females rather than 5 and 5 as suggested by the reviewer.
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Evaluation of non-invasive lactate sensor
Arm Type
Experimental
Arm Description
To determine the efficacy and accuracy of the non-invasive lactate sensor
Intervention Type
Device
Intervention Name(s)
Lactate sensor (Lactisense)
Intervention Description
Non-invasive monitoring of interstitial lactate levels during and after exercise.
Primary Outcome Measure Information:
Title
That the lactate sensor under test is able track increase in interstitial lactate levels in exercising humans that follow the same time course as lactate values obtained from a commercial blood capillary lactate monitor.
Description
The novel sensor data will be compared to lactate values measured simultaneously with a commercial blood capillary lactate monitor in exercising humans.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy and physically active volunteers Exclusion Criteria: Existing health conditions e.g blood pressure > 150/95, joint injury that would contraindicate exercise. Individuals who answer "yes" to any of the health condition questions on the PAR-Q questionnaire will also be excluded. As ketones might interfere with the sensor signal, we will exclude anyone with metabolic conditions or following a ketogenic diet.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter E Light, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Diabetes Institute, University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2E1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilot Testing a Novel Non-invasive Lactate Sensor

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