Insulin ResistanceNCT03615209
Effect of Vagus Stimulation on Peripheral Glucose Metabolism
A study testing Transauricular vagus nerve stimulation in people with Insulin Resistance and Glucose Intolerance, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Glucose Intolerance
- What is being tested?
- Transauricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jul 2018to 20 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HbA1c <6.5%
- Must be able to understand the explanations of the study and the instructions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Tuebingen, Department of Internal Medicine IV
Tübingen, 72076
About this study
Official title: Effekte Der Transkutanen Aurikularen Vagus-Nervenstimulation (tVNS) Auf Die Postprandiale Stoffwechselregulation im Menschen
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.
Read more
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
- Being tested
- Transauricular vagus nerve stimulation, Transauricular sham stimulation
- Medical subject headings
- Insulin Resistance, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transauricular vagus nerve stimulationDevice
Stimulation will be performed for 150 minutes (throughout the entire OGTT).
Transauricular sham stimulationDevice
Sham stimulation will be performed for 150 minutes (throughout the entire OGTT)
| Study group | Role | What they receive |
|---|---|---|
| Transauricular vagus nerve stimulation | Active comparator | Non invasive vagus nerve stimulation will be conducted with Cerbomed NEMOS via the left ear. Receives: 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. Receives: Device: Transauricular sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body insulin sensitivity
Insulin sensitivity will be assessed by a 75g OGTT.
Measured: 0-120 min
Secondary outcomes (4)
Insulin secretion
Insulin secretion will be assessed by a 75g OGTT
Measured: 0-120 min
Glucose tolerance
Glucose tolerance will be assessed by a 75g OGTT
Measured: 0-120 min
Resting energy expenditure
Resting energy expenditure will be assessed by indirect calorimetry
Measured: 140-160 min. after start of stimulation
Heart rate variability
Heart rate variability will be assessed from continuous ecg recordings
Measured: -30 - 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start25 Jul 2018
- Primary completion1 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Heni, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615209
- Sponsor's protocol ID
- 608/2017BO1
- Status last verified
- Jul 2018
- First submitted
- 30 Jul 2018
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical restrains, we will not be able to share patient level data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effekte Der Transkutanen Aurikularen Vagus-Nervenstimulation (tVNS) Auf Die Postprandiale Stoffwechselregulation im Menschen
- ClinicalTrials.gov ID
- NCT03615209
- Acronym / sponsor ID
- 608/2017BO1
- Conditions
- Insulin Resistance, Glucose Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transauricular vagus nerve stimulation | Active comparator | Device: Transauricular vagus nerve stimulationNon invasive vagus nerve stimulation will be conducted with Cerbomed NEMOS via the left ear. |
| Transauricular sham stimulation | Sham comparator | Device: Transauricular sham stimulationNon invasive sham stimulation will be conducted with Cerbomed NEMOS via the left ear lobe. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HbA1c <6.5%
- Must be able to understand the explanations of the study and the instructions
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transauricular vagus nerve stimulationStimulation will be performed for 150 minutes (throughout the entire OGTT). | Device | Transauricular vagus nerve stimulation |
| Transauricular sham stimulationSham stimulation will be performed for 150 minutes (throughout the entire OGTT) | Device | Transauricular sham stimulation |
Primary outcome
Whole body insulin sensitivity
Time frame: 0-120 min
Insulin sensitivity will be assessed by a 75g OGTT.
4 secondary outcomes
Insulin secretion
Time frame: 0-120 min
Glucose tolerance
Time frame: 0-120 min
Resting energy expenditure
Time frame: 140-160 min. after start of stimulation
Heart rate variability
Time frame: -30 - 120 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Individual participant dataSharing planned: No. Due to ethical restrains, we will not be able to share patient level data.
Related trials for Insulin Resistance
Active, not recruiting
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Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
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Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
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Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
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Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Heni, MD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transauricular vagus nerve stimulation in people with Insulin Resistance and Glucose Intolerance, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole body insulin sensitivity (time frame: 0-120 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.