Insulin Resistance Clinical Trial
Official title:
Effekte Der Transkutanen Aurikularen Vagus-Nervenstimulation (tVNS) Auf Die Postprandiale Stoffwechselregulation im Menschen
Verified date | July 2018 |
Source | University Hospital Tuebingen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 15 |
Est. completion date | December 20, 2018 |
Est. primary completion date | December 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - HbA1c <6.5% - Must be able to understand the explanations of the study and the instructions Exclusion Criteria: - Any relevant (according to investigator's judgment) cardiovascular disease - Neurological and psychiatric disorders - Diabetes mellitus - Active implants (e.g. pacemaker, cochlear implant, cerebral shunt) - asthma - skin diseases on the ear |
Country | Name | City | State |
---|---|---|---|
Germany | University of Tuebingen, Department of Internal Medicine IV | Tübingen |
Lead Sponsor | Collaborator |
---|---|
University Hospital Tuebingen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Whole body insulin sensitivity | Insulin sensitivity will be assessed by a 75g OGTT. | 0-120 min | |
Secondary | Insulin secretion | Insulin secretion will be assessed by a 75g OGTT | 0-120 min | |
Secondary | Glucose tolerance | Glucose tolerance will be assessed by a 75g OGTT | 0-120 min | |
Secondary | Resting energy expenditure | Resting energy expenditure will be assessed by indirect calorimetry | 140-160 min. after start of stimulation | |
Secondary | Heart rate variability | Heart rate variability will be assessed from continuous ecg recordings | -30 - 120 min |
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