Effect of Vagus Stimulation on Peripheral Glucose Metabolism

NCT03615209 | Completed

• 1 other identifier: 608/2017BO1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Whole body insulin sensitivity

  Insulin sensitivity will be assessed by a 75g OGTT.

  0-120 min

Secondary Outcomes (4)

• Insulin secretion

  0-120 min

• Glucose tolerance

  0-120 min

• Resting energy expenditure

  140-160 min. after start of stimulation

• Heart rate variability

  -30 - 120 min

Study Arms (2)

Transauricular vagus nerve stimulation

ACTIVE COMPARATOR

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

Device: Transauricular vagus nerve stimulation

Transauricular sham stimulation

SHAM COMPARATOR

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

Device: Transauricular sham stimulation

Interventions

Transauricular vagus nerve stimulation DEVICE

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

Transauricular vagus nerve stimulation

Transauricular sham stimulation DEVICE

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

Transauricular sham stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HbA1c \<6.5%
• Must be able to understand the explanations of the study and the instructions

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University of Tuebingen, Department of Internal Medicine IV

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Insulin Resistance; Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia

Study Officials

• Martin Heni, MD

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 3, 2018
• Study Start: July 25, 2018
• Primary Completion: December 1, 2018
• Study Completion: December 20, 2018
• Last Updated: January 10, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)