Effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Plasma Insulin Levels
ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorIndiana University
About this trial
The vagus or vagal nerve is a nerve that sends signals from the brain to other parts of the body to control involuntary functionm, including stomach function, and it is important to the regulation of insulin, C-peptide, and glucose levels. The purpose of this study is to evaluate whether electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve and influence the levels of insulin, C-peptide, and glucose. If it does, investigators hope that this will help innovate treatment of patients with nausea, vomiting, and disordered stomach function, and patients with diabetes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy Volunteers
Aged 18-70
Willing to have ECG electrodes placed on their neck and chest areas.
Willing to have electrodes placed in the external ear.
Disqualifiers
Unable to provide consent.
Diabetes diagnosis per patient report
Having known allergies to adhesive on electrode pads or bandages
Having gastric motility issues as determined by the PI or clinical coordinator.
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous Auricular Vagus Nerve Stimulation
DeviceFor participants in the active stimulation group, electrical stimuli are delivered continuously for 40 minutes at a pulse width of 300 microseconds, pulse frequency of 25 Hz, and pulse amplitude of 0.5 to 1.5 mA based on the tolerance of the patient. Stimuli current and frequency may be decreased, if necessary, to minimize participant discomfort.
Sham Procedure (No Stimulation)
DeviceThe TENS device will be placed but not turned on.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Active Stimulation, then No electrodesExperimental treatment 1 intervention
Group B: Sham Stimulation, then No ElectrodesSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in plasma insulin levels
Repeated measures analysis of variance will be used to determine the effects of stimulation period (baseline, end of stimulation, end of non-stimulation) and active/control group on plasma insulin levels.
Time frame
Study Days 1 and 22
Change in C-peptide levels
Repeated measures analysis of variance will be used to determine the effects of stimulation period (baseline, end of stimulation, end of non-stimulation) and active/control group on C-peptide levels.
Time frame
Study Days 1 and 23
Change in glucose levels
Repeated measures analysis of variance will be used to determine the effects of stimulation period (baseline, end of stimulation, end of non-stimulation) and active/control group on glucose levels
Time frame
Study Days 1 and 24
Change in heart rate variability
Repeated measures analysis of variance will be used to determine the effects of stimulation period (baseline, end of stimulation, end of non-stimulation) and active/control group on heart rate variability.
Time frame
Study Days 1 and 2Secondary outcomes
1
Correlation between gender and changes in circulating plasma insulin levels
Pearson's correlation coefficient will be calculated for the association between change in circulating plasma insulin levels (end of stimulation minus baseline) and patient gender.
Time frame
Study Days 1 and 22
Correlation between age and changes in circulating plasma insulin levels
Pearson's correlation coefficient will be calculated for the association between change in circulating plasma insulin levels (end of stimulation minus baseline) and patient age.
Time frame
Study Days 1 and 23
Correlation between body mass index and changes in circulating plasma insulin levels
Pearson's correlation coefficient will be calculated for the association between change in circulating plasma insulin levels (end of stimulation minus baseline) and patient body mass index.
Time frame
Study Days 1 and 2Sponsors and contacts
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Source ClinicalTrials.gov