Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Insulin Levels
This study is looking at whether a device called Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) can change insulin, C-peptide (a substance made when insulin is produced), and glucose (sugar) levels in healthy adults. Researchers will place electrodes on your ear to deliver mild stimulation to the vagus nerve, which runs from your brain to your large intestine and controls many body functions. You might be in a group that receives stimulation or a group that doesn't, but thinks they are. The goal is to see if stimulating this nerve can affect insulin levels, which could help people with nausea, vomiting, stomach problems, or diabetes in the future. We are looking for healthy volunteers aged 18-70.
- Study design
- This interventional study plans to enroll 30 healthy adult participants. You will be assigned to either a stimulation group or a sham group, where you believe you are receiving stimulation but are not.
- What's involved
- You will need to be willing to have ECG electrodes placed on your neck and chest, electrodes placed in your external ear, and an indwelling catheter for blood draws. The primary measurements will be taken at one month.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your plasma insulin, C-peptide, and glucose levels will be measured at one month after the stimulation.
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Effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Plasma Insulin Levels
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Thomas V Nowak, MD · PRINCIPAL_INVESTIGATOR · IU Medical Scool
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Association between acute transcutaneous auricular vagus nerve stimulation and change in plasma insulin levelsone month
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.
- Association between acute transcutaneous auricular vagus nerve stimulation and change in C-peptide levelsone month
\- Measure description: 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.
- Association between acute transcutaneous auricular vagus nerve stimulation and change in glucose levelsone month
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
- Association between acute transcutaneous auricular vagus nerve stimulation and heart rate variabilityone month
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.
- Association between changes in heart rate variability and plasma insulin levelsone month
Pearson's correlation coefficients will be used to evaluate the association between change in heart rate variability (end of stimulation minus baseline) with changes in plasma insulin levels (end of stimulation minus baseline). Heart rate variability will be used as an indication of changes in parasympathetic or sympathetic activation.
- Association between changes in heart rate variability and C-peptide levelsone month
Pearson's correlation coefficients will be used to evaluate the association between change in heart rate variability (end of stimulation minus baseline) with changes in C-peptide levels (end of stimulation minus baseline). Heart rate variability will be used as an indication of changes in parasympathetic or sympathetic activation.
- Association between changes in heart rate variability and glucose levelsone month
Pearson's correlation coefficients will be used to evaluate the association between change in heart rate variability (end of stimulation minus baseline) with changes in glucose levels (end of stimulation minus baseline). Heart rate variability will be used as an indication of changes in parasympathetic or sympathetic activation.