Effect of Vagus Stimulation on Peripheral Glucose Metabolism

Not Applicable

Completed

• Conditions: Glucose Intolerance; Insulin Resistance
• Interventions: Device: Transauricular vagus nerve stimulation; Device: Transauricular sham stimulation

• Registration Number: NCT03615209
• Lead Sponsor: University Hospital Tuebingen

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-07
• Study Start: 2018-07-25
• Study First Submitted: 2018-07-30
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-08-03
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-20
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Transauricular vagus nerve stimulation	Transauricular vagus nerve stimulation	Non invasive vagus nerve stimulation will be conducted with Cerbomed NEMOS via the left ear.
Transauricular sham stimulation	Transauricular sham stimulation	Non invasive sham stimulation will be conducted with Cerbomed NEMOS via the left ear lobe.

Primary Outcome Measures

Name	Time	Method
Whole body insulin sensitivity	0-120 min	Insulin sensitivity will be assessed by a 75g OGTT.

Secondary Outcome Measures

Name	Time	Method
Insulin secretion	0-120 min	Insulin secretion will be assessed by a 75g OGTT
Glucose tolerance	0-120 min	Glucose tolerance will be assessed by a 75g OGTT
Heart rate variability	-30 - 120 min	Heart rate variability will be assessed from continuous ecg recordings
Resting energy expenditure	140-160 min. after start of stimulation	Resting energy expenditure will be assessed by indirect calorimetry

Trial Locations

Locations (1)

University of Tuebingen, Department of Internal Medicine IV; 🇩🇪 Tübingen, Germany