Vagus Nerve StimulationRESPI01NCT04150627
Effect of Breathing Maneuvers on Peripheral Glucose Metabolism
A study testing deep breathing in people with Vagus Nerve Stimulation and Insulin Sensitivity, 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
- Vagus Nerve Stimulation, Insulin Sensitivity, Deep Breathing Maneuver
- What is being tested?
- deep breathing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2019to 1 Apr 2020
- 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
- Asthma
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Tuebingen, Department of Internal Medicine IV
Tübingen, 72076
About this study
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.
Deep breathing exercise can increase parasympathetic nerve activity. Heart rate variability (HRV) in healthy people can be significantly increased by deep breathing maneuvers, 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 deep breathing exercise versus normal breathing on insulin sensitivity, on insulin secretion, glucose tolerance, resting energy expenditure, and on parasympathetic tone (analysis of heart rate variability).
- Being tested
- deep breathing
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep breathingOther
Deep breathing maneuver to increase parasympathetic nerve activity
| Study group | Role | What they receive |
|---|---|---|
| deep breathing | Active comparator | Not described Receives: Other: deep breathing |
| normal breathing | No intervention | Not described |
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 breathing maneuver
Heart rate variability
Heart rate variability will be assessed from continuous ecg recordings
Measured: -35 - 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Nov 2019
- Primary completion1 Mar 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vagus Nerve StimulationStudies 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
- None (open label)
- Enrolment
- 16 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
- NCT04150627
- Sponsor's protocol ID
- 039/2019B02
- Acronym
- RESPI01
- Status last verified
- Oct 2019
- First submitted
- 31 Oct 2019
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breathing Maneuvers on Peripheral Glucose Metabolism
- ClinicalTrials.gov ID
- NCT04150627
- Acronym / sponsor ID
- RESPI01 / 039/2019B02
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 5 Nov 2019 (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.
Deep breathing exercise can increase parasympathetic nerve activity. Heart rate variability (HRV) in healthy people can be significantly increased by deep breathing maneuvers, 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 deep breathing exercise versus normal breathing 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
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deep breathing | Active comparator | Other: deep breathing |
| normal breathing | No intervention | – |
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 (4 listed)
- Any relevant (according to investigator's judgment) cardiovascular disease
- Neurological and psychiatric disorders
- Diabetes mellitus
- 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 |
|---|---|---|
| deep breathingDeep breathing maneuver to increase parasympathetic nerve activity | Other | deep breathing |
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 breathing maneuver
Heart rate variability
Time frame: -35 - 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 17 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Vagus Nerve Stimulation
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
taVNS in Infants Severe Dysphagia
Dysphagia, Swallowing Disorders
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Chronic Kidney Disease
Recruiting
Identification of Biomarkers for Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
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 deep breathing in people with Vagus Nerve Stimulation and Insulin Sensitivity, 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 4 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 17 Jun 2020. 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. 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 17 Jun 2020.