Clinical trial NCT05649358: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlactatemia
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Alberta Diabetes Institute, University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Peter E Light, PhD
role: PRINCIPAL_INVESTIGATOR
References: