Effect of Vagus Stimulation on Peripheral Glucose Metabolism

Insulin Resistance Clinical Trial

Official title:

Effekte Der Transkutanen Aurikularen Vagus-Nervenstimulation (tVNS) Auf Die Postprandiale Stoffwechselregulation im Menschen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03615209
• Other study ID #: 608/2017BO1
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Glucose Intolerance
• Insulin Resistance

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