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Completed

NCT Number: NCT03615209

Effect of Vagus Stimulation on Peripheral Glucose Metabolism

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).

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Tuebingen, Department of Internal Medicine IV

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transauricular Vagus Nerve Stimulation

Device

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

Transauricular sham stimulation

Device

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

Primary outcomes

  1. Whole body insulin sensitivity

    Time frame: 0-120 min

    Insulin sensitivity will be assessed by a 75g OGTT.

Secondary outcomes

  1. Insulin secretion

    Time frame: 0-120 min

    Insulin secretion will be assessed by a 75g OGTT

  2. Glucose tolerance

    Time frame: 0-120 min

    Glucose tolerance will be assessed by a 75g OGTT

  3. Resting energy expenditure

    Time frame: 140-160 min. after start of stimulation

    Resting energy expenditure will be assessed by indirect calorimetry

  4. Heart rate variability

    Time frame: -30 - 120 min

    Heart rate variability will be assessed from continuous ecg recordings

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 3, 2018
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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