Effect of Vagus Stimulation on Peripheral Glucose Metabolism

NCT ID: NCT03615209

Last Updated: 2019-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-25
• Study Completion Date: 2018-12-20

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).

Conditions

Insulin Resistance; Glucose Intolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Transauricular vagus nerve stimulation

Non invasive vagus nerve stimulation will be conducted with Cerbomed NEMOS via the left ear.

Group Type: ACTIVE_COMPARATOR

Transauricular vagus nerve stimulation

Intervention Type: DEVICE

Stimulation will be performed for 150 minutes (throughout the entire OGTT).

Transauricular sham stimulation

Non invasive sham stimulation will be conducted with Cerbomed NEMOS via the left ear lobe.

Group Type: SHAM_COMPARATOR

Transauricular sham stimulation

Intervention Type: DEVICE

Sham stimulation will be performed for 150 minutes (throughout the entire OGTT)

Interventions

Transauricular vagus nerve stimulation

Stimulation will be performed for 150 minutes (throughout the entire OGTT).

Intervention Type: DEVICE

Transauricular sham stimulation

Sham stimulation will be performed for 150 minutes (throughout the entire OGTT)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Heni, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

University of Tuebingen, Department of Internal Medicine IV

Tübingen, , Germany

Countries

Germany

Other Identifiers

608/2017BO1

Identifier Type: -

Identifier Source: org_study_id