Effect of Vagus Stimulation on Peripheral Glucose Metabolism
Primary Purpose
Insulin Resistance, Glucose Intolerance
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Transauricular vagus nerve stimulation
Transauricular sham stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Insulin Resistance
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
Sites / Locations
- University of Tuebingen, Department of Internal Medicine IV
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Transauricular vagus nerve stimulation
Transauricular sham stimulation
Arm Description
Non invasive vagus nerve stimulation will be conducted with Cerbomed NEMOS via the left ear.
Non invasive sham stimulation will be conducted with Cerbomed NEMOS via the left ear lobe.
Outcomes
Primary Outcome Measures
Whole body insulin sensitivity
Insulin sensitivity will be assessed by a 75g OGTT.
Secondary Outcome Measures
Insulin secretion
Insulin secretion will be assessed by a 75g OGTT
Glucose tolerance
Glucose tolerance will be assessed by a 75g OGTT
Resting energy expenditure
Resting energy expenditure will be assessed by indirect calorimetry
Heart rate variability
Heart rate variability will be assessed from continuous ecg recordings
Full Information
NCT ID
NCT03615209
First Posted
July 30, 2018
Last Updated
January 9, 2019
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT03615209
Brief Title
Effect of Vagus Stimulation on Peripheral Glucose Metabolism
Official Title
Effekte Der Transkutanen Aurikularen Vagus-Nervenstimulation (tVNS) Auf Die Postprandiale Stoffwechselregulation im Menschen
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 25, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Glucose Intolerance
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transauricular vagus nerve stimulation
Arm Type
Active Comparator
Arm Description
Non invasive vagus nerve stimulation will be conducted with Cerbomed NEMOS via the left ear.
Arm Title
Transauricular sham stimulation
Arm Type
Sham Comparator
Arm Description
Non invasive sham stimulation will be conducted with Cerbomed NEMOS via the left ear lobe.
Intervention Type
Device
Intervention Name(s)
Transauricular vagus nerve stimulation
Intervention Description
Stimulation will be performed for 150 minutes (throughout the entire OGTT).
Intervention Type
Device
Intervention Name(s)
Transauricular sham stimulation
Intervention Description
Sham stimulation will be performed for 150 minutes (throughout the entire OGTT)
Primary Outcome Measure Information:
Title
Whole body insulin sensitivity
Description
Insulin sensitivity will be assessed by a 75g OGTT.
Time Frame
0-120 min
Secondary Outcome Measure Information:
Title
Insulin secretion
Description
Insulin secretion will be assessed by a 75g OGTT
Time Frame
0-120 min
Title
Glucose tolerance
Description
Glucose tolerance will be assessed by a 75g OGTT
Time Frame
0-120 min
Title
Resting energy expenditure
Description
Resting energy expenditure will be assessed by indirect calorimetry
Time Frame
140-160 min. after start of stimulation
Title
Heart rate variability
Description
Heart rate variability will be assessed from continuous ecg recordings
Time Frame
-30 - 120 min
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Heni, MD
Organizational Affiliation
University Hospital Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tuebingen, Department of Internal Medicine IV
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Due to ethical restrains, we will not be able to share patient level data.
Learn more about this trial
Effect of Vagus Stimulation on Peripheral Glucose Metabolism
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