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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03615209
Other study ID # 608/2017BO1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 25, 2018
Est. completion date December 20, 2018

Study information

Verified date July 2018
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Transauricular vagus nerve stimulation
Stimulation will be performed for 150 minutes (throughout the entire OGTT).
Transauricular sham stimulation
Sham stimulation will be performed for 150 minutes (throughout the entire OGTT)

Locations

Country Name City State
Germany University of Tuebingen, Department of Internal Medicine IV Tübingen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

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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