Effect of Vagus Stimulation on Peripheral Glucose Metabolism

• Sponsor: University Hospital Tuebingen (Other)
• Overall Status: Completed
• CT.gov ID: NCT03615209
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.9
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Insulin Resistance; Glucose Intolerance	Device: Transauricular vagus nerve stimulation; Device: Transauricular sham stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Effekte Der Transkutanen Aurikularen Vagus-Nervenstimulation (tVNS) Auf Die Postprandiale Stoffwechselregulation im Menschen
• Actual Study Start Date: Jul 25, 2018
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Dec 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Transauricular vagus nerve stimulation Non invasive vagus nerve stimulation will be conducted with Cerbomed NEMOS via the left ear.	Device: Transauricular vagus nerve stimulation; Stimulation will be performed for 150 minutes (throughout the entire OGTT).
Sham Comparator: Transauricular sham stimulation Non invasive sham stimulation will be conducted with Cerbomed NEMOS via the left ear lobe.	Device: Transauricular sham stimulation; Sham stimulation will be performed for 150 minutes (throughout the entire OGTT)

Outcome Measures

Primary Outcome Measures

1. Whole body insulin sensitivity [0-120 min]

   Insulin sensitivity will be assessed by a 75g OGTT.

Secondary Outcome Measures

1. Insulin secretion [0-120 min]

   Insulin secretion will be assessed by a 75g OGTT

2. Glucose tolerance [0-120 min]

   Glucose tolerance will be assessed by a 75g OGTT

3. Resting energy expenditure [140-160 min. after start of stimulation]

   Resting energy expenditure will be assessed by indirect calorimetry

4. Heart rate variability [-30 - 120 min]

   Heart rate variability will be assessed from continuous ecg recordings

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Tuebingen, Department of Internal Medicine IV	Tübingen		Germany	72076

Sponsors and Collaborators

• University Hospital Tuebingen

Investigators

• Principal Investigator: Martin Heni, MD, University Hospital Tuebingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital Tuebingen
• ClinicalTrials.gov Identifier: NCT03615209
• Other Study ID Numbers: 608/2017BO1
• First Posted: Aug 3, 2018
• Last Update Posted: Jan 10, 2019
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Insulin Resistance; Glucose Intolerance

Study Results

No Results Posted as of Jan 10, 2019