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Clinical Trials/NCT03615209
NCT03615209
Completed
Not Applicable

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

University Hospital Tuebingen1 site in 1 country15 target enrollmentJuly 25, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Insulin Resistance
Sponsor
University Hospital Tuebingen
Enrollment
15
Locations
1
Primary Endpoint
Whole body insulin sensitivity
Status
Completed
Last Updated
7 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
July 25, 2018
End Date
December 20, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Responsible Party
Sponsor

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)
  • skin diseases on the ear

Outcomes

Primary Outcomes

Whole body insulin sensitivity

Time Frame: 0-120 min

Insulin sensitivity will be assessed by a 75g OGTT.

Secondary Outcomes

  • Insulin secretion(0-120 min)
  • Glucose tolerance(0-120 min)
  • Heart rate variability(-30 - 120 min)
  • Resting energy expenditure(140-160 min. after start of stimulation)

Study Sites (1)

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