An interventional study of Lactate sensor (Lactisense) in Hyperlactatemia, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-05.
Sponsored by University of Alberta · Not applicable, Interventional, and Device feasibility
To test the efficacy and accuracy of a novel non-invasive lactate sensor in humans undergoing strenuous leg exercise.
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.
50 studies on the registry are indexed under Hyperlactatemia; 7 are open to participants now.
This study's enrollment of 9 is below the median of 38 across 32 interventional studies indexed under Hyperlactatemia.
Browse Hyperlactatemia studies →University of Alberta is the lead sponsor of 823 studies on the registry; 169 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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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.
To determine the efficacy and accuracy of the non-invasive lactate sensor
Device: Lactate sensor (Lactisense)
Non-invasive monitoring of interstitial lactate levels during and after exercise.
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.
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2022 to primary completion in Aug 2023, 8 months.
Of 17 interventional studies with no phase under Hyperlactatemia, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 12. This study's 8 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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