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Two important mechanisms play a major role in the pathogenesis of type 2 diabetes: insulin resistance of the target tissues and the impaired insulin secretion from pancreatic β-cells. Postprandial factors (such as insulin) are perceived by the human brain and induce signals that regulate glucose metabolism via the parasympathetic nervous system.
Transcutaneous auricular vagus nerve stimulation (tVNS) can be used on the outer ear to stimulate the auricular branch of the vagus nerve in humans. Heart rate variability (HRV) in healthy people can be significantly increased via tVNS, indicating a shift from sympathetic activity to parasympathetic activity.
The hypothesis is that this postprandial shift results in a change in peripheral glucose metabolism. In turn, the increased parasympathetic activity could potentially result in a change in postprandial insulin sensitivity or secretion.
To test this hypothesis, this study investigates the effect of vagal stimulation versus sham stimulation on insulin sensitivity, on insulin secretion, glucose tolerance, resting energy expenditure, and on parasympathetic tone (analysis of heart rate variability).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transauricular vagus nerve stimulation | Active Comparator | Non invasive vagus nerve stimulation will be conducted with Cerbomed NEMOS via the left ear. |
|
| Transauricular sham stimulation | Sham Comparator | Non invasive sham stimulation will be conducted with Cerbomed NEMOS via the left ear lobe. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transauricular vagus nerve stimulation | Device | Stimulation will be performed for 150 minutes (throughout the entire OGTT). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Whole body insulin sensitivity | Insulin sensitivity will be assessed by a 75g OGTT. | 0-120 min |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin secretion | Insulin secretion will be assessed by a 75g OGTT | 0-120 min |
| Glucose tolerance | Glucose tolerance will be assessed by a 75g OGTT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Heni, MD | University Hospital Tuebingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tuebingen, Department of Internal Medicine IV | Tübingen | 72076 | Germany |
Due to ethical restrains, we will not be able to share patient level data.
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Transauricular sham stimulation | Device | Sham stimulation will be performed for 150 minutes (throughout the entire OGTT) |
|
| 0-120 min |
| Resting energy expenditure | Resting energy expenditure will be assessed by indirect calorimetry | 140-160 min. after start of stimulation |
| Heart rate variability | Heart rate variability will be assessed from continuous ecg recordings | -30 - 120 min |
| D006943 | Hyperglycemia |