Diabetes Mellitus, Type 2NCT04926415
Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Obesity and Insulin Resistance
A study testing taVNS in people with Diabetes Mellitus, Type 2 and Obesity, run by Burrell College of Health Sciences at 1 site in United States.
Trial summary
Being overweight or obese has been associated with insulin resistance contributing to an increased risk for the development of type II diabetes. Food intake, metabolic rate, and blood glucose levels are regulated by the autonomic nervous system, including the vagus nerve. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity
- What is being tested?
- taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2021to 26 Apr 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy
Who cannot join
- Age under 18 years
- Pregnancy
- Acute illnesses/fever
- Any medication that interferes with the autonomic nervous system (e.g., beta blockers)
- Any medication that interferes with glucose metabolism (e.g., antidiabetic drugs)
- Any medication that interferes with lipid metabolism (e.g., statins)
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- Any medical conditions that interfere with the autonomic nervous system
- Type 1 or Type 2 diabetes
- Epilepsy
- Cardiac conditions, including arrhythmia
- Vestibulocochlear neuronitis or nerve damage (e.g., hearing loss or tinnitus)
- Skin irritation/inflammation at the stimulation site at the ear
- Current drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Burrell College of Osteopathic Medicine
Las Cruces, New Mexico, 88001
About this study
Being overweight or obese has been associated with insulin resistance contributing to an increased risk for the development of type II diabetes. Food intake, metabolic rate, and blood glucose levels are regulated by the autonomic nervous system, including the vagus nerve. This study evaluates the hypothesis that non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) affects hormones that regulate food intake and blood glucose levels in a way that is consistent with reduced food intake and lower blood glucose levels. The investigators further hypothesize that these effects of taVNS depend on body weight. In a cross-over design generally healthy study participants will receive either taVNS or a sham intervention for 30 minutes on two separate study days. The order of the intervention on the two study days will be randomized and the two study days are at least one week apart. Based on body mass index (BMI) study participants are assigned to either a normal weight (BMI<25), overweight (BMI<30), or obese (BMI>30) group. Capillary blood samples taken by finger prick before and after the intervention on each study day will be analyzed for blood glucose concentration and hormones that are linked to food intake and blood glucose levels. In addition, autonomic function will be assessed by heart rate variability analysis of ECG recordings obtained before, during, and after the intervention on each study day.
Read the detailed description
Clinical studies and experimental studies in animals have demonstrated that cervical vagus nerve stimulation causes weight loss in obese patients and has profound effects on glucose homeostasis. Furthermore, anorexic and antidiabetic effects have been reported in response to non-invasive transcutaneous auricular vagus nerve stimulation (taVNS). Thus, non-invasive taVNS may potentially prevent insulin resistance in obesity. The objective of this study is to investigate the acute effects of taVNS on hormones and adipokines linking obesity with insulin resistance in human subjects. The hypothesis of this study is that acute application of taVNS elicits anti-diabetic effects through modulation of plasma levels of insulin, glucagon, C-peptide, GLP-1 (stimulates insulin and suppresses glucagon release), and GIP (gastric inhibitory polypeptide, stimulates insulin secretion). Furthermore, the investigators hypothesize that taVNS elicits anorexic effects by modulating ghrelin and leptin plasma levels. Finally the investigators hypothesize that taVNS may reduce the impact of obesity on insulin resistance by modulating PAI-1 (plasminogen activator inhibitor-1; increased in obesity and metabolic syndrome), resistin (adipose tissue secretory factor, suggested to link obesity with insulin resistance), vistatin (enriched in visceral fat and may stimulate the insulin receptor), adipsin (secreted from adipocytes; improves β-cell function), and adiponectin (secreted from adipose tissue; increases insulin sensitivity). In normal weight (BMI<25, n=14), overweight (BMI<30, n=14), and obese (BMI>30, n=14) and otherwise healthy study participants blood glucose levels and plasma concentrations (finger prick blood sampling) of insulin, glucagon, C-peptide, GLP-1, GIP, ghrelin, leptin, PAI-1, resistin, vistatin (Bio-Plex kit 171A7001M), adipsin, and adiponectin (Bio-Plex kit 171A7002M) will be determined before and after 30 minutes of taVNS (EMS 7500, 10 Hz, 300ms, n=7 in each body weight group) or sham taVNS (control experiment, n=7 in each body weight group). Before, during and after taVNS or sham taVNS autonomic function will be assessed by heart rate variability analysis from ECG recordings. The investigators expect that the outcome of this study will demonstrate that taVNS lowers blood glucose levels and elicits hormone/adipokine responses consistent with anorexia and improved insulin resistance. The investigators further hypothesize that these effects of taVNS will be more pronounced in obese compared to overweight and normal weight study participants.
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Being tested
- taVNS, Sham taVNS
- Keywords
- insulin resistance, blood glucose, insulin, glucagon, C-peptide, GLP-1, GIP, ghrelin, leptin, PAI-1, resistin, vistatin, adipsin, adiponectin, vagus nerve stimulation, transcutaneous auricular vagus nerve stimulation
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNSDevice
Also called Transcutaneous Auricular Vagus Nerve Stimulation
A bipolar clip electrode is attached to the auricle at the location of the cymba conchae. Electrical stimulation (30 Hz stimulation frequency, 300 μs pulse width) is applied for 30 min. The stimulation current is determined individually for each participant by slowly increasing the stimulation current until the participants feel a mild tingling sensation at the site of the electrode. Then the current is gradually reduced until the tingling sensation disappears. This current will then be used for taVNS. A TENS 7000 or EMS 7500 device (510(k): K080661) is used.
Sham taVNSDevice
Also called Sham Transcutaneous Auricular Vagus Nerve Stimulation
A bipolar clip electrode is attached to the auricle at the location of the cymba conchae but no electrical current is applied to the electrode.
| Study group | Role | What they receive |
|---|---|---|
| Normal Weight | Experimental | This arm consists of study participants with a body mass index (BMI) of less than 25. These study participants will participate on two study days. On one study day non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) and on the other study day a sham procedure will be performed. Capillary blood samples (finger prick) will be obtained before and after the interventions on both study days. The ECG will be recorded before, during, and after the intervention on both study days. Receives: Device: taVNS; Device: Sham taVNS |
| Overweight | Experimental | This arm consists of study participants with a body mass index (BMI) of more than 25 but less than 30. These study participants will participate on two study days. On one study day non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) and on the other study day a sham procedure will be performed. Capillary blood samples (finger prick) will be obtained before and after the interventions on both study days. The ECG will be recorded before, during, and after the intervention on both study days. Receives: Device: taVNS; Device: Sham taVNS |
| Obese | Experimental | This arm consists of study participants with a body mass index (BMI) of more than 30. These study participants will participate on two study days. On one study day non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) and on the other study day a sham procedure will be performed. Capillary blood samples (finger prick) will be obtained before and after the interventions on both study days. The ECG will be recorded before, during, and after the intervention on both study days. Receives: Device: taVNS; Device: Sham taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood Glucose Concentration induced by taVNS
The blood glucose concentration is measured before and after application of taVNS from capillary blood samples obtained by finger prick. The change in blood glucose concentration is determined as the difference in the two blood glucose concentrations (after taVNS minus before taVNS).
Measured: During the taVNS intervention (30 min).
Change in Blood Glucose Concentration induced by sham taVNS
The blood glucose concentration is measured before and after application of sham taVNS from capillary blood samples obtained by finger prick. The change in blood glucose concentration is determined as the difference in the two blood glucose concentrations (after sham taVNS minus before sham taVNS).
Measured: During the sham taVNS intervention (30 min).
Change in Insulin Plasma Concentration induced by taVNS
Using capillary blood samples obtained by finger prick the insulin plasma concentration will be determined using a Bioplex assay. The insulin plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Measured: During the taVNS intervention (30 min).
Change in Insulin Plasma Concentration induced by sham taVNS
Using capillary blood samples obtained by finger prick the insulin plasma concentration will be determined using a Bioplex assay. The insulin plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Measured: During the taVNS intervention (30 min).
Change in Glucagon Plasma Concentration induced by taVNS
Using capillary blood samples obtained by finger prick the glucagon plasma concentration will be determined using a Bioplex assay. The glucagon plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Measured: During the taVNS intervention (30 min).
Change in Glucagon Plasma Concentration induced by sham taVNS
Using capillary blood samples obtained by finger prick the glucagon plasma concentration will be determined using a Bioplex assay. The glucagon plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Measured: During the taVNS intervention (30 min).
Change in C-Peptide Plasma Concentration induced by taVNS
Using capillary blood samples obtained by finger prick the C-peptide plasma concentration will be determined using a Bioplex assay. The C-peptide plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Measured: During the taVNS intervention (30 min).
Change in C-Peptide Plasma Concentration induced by sham taVNS
Using capillary blood samples obtained by finger prick the C-peptide plasma concentration will be determined using a Bioplex assay. The C-peptide plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Measured: During the taVNS intervention (30 min).
Change in GLP-1 Plasma Concentration induced by taVNS
Using capillary blood samples obtained by finger prick the GLP-1 plasma concentration will be determined using a Bioplex assay. The GLP-1 plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Measured: During the taVNS intervention (30 min).
Change in GLP-1 Plasma Concentration induced by sham taVNS
Using capillary blood samples obtained by finger prick the GLP-1 plasma concentration will be determined using a Bioplex assay. The GLP-1 plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Measured: During the taVNS intervention (30 min).
Change in GIP Plasma Concentration induced by taVNS
Using capillary blood samples obtained by finger prick the GIP plasma concentration will be determined using a Bioplex assay. The GIP plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Measured: During the taVNS intervention (30 min).
Change in GIP Plasma Concentration induced by sham taVNS
Using capillary blood samples obtained by finger prick the GIP plasma concentration will be determined using a Bioplex assay. The GIP plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Measured: During the taVNS intervention (30 min).
Change in Ghrelin Plasma Concentration induced by taVNS
Using capillary blood samples obtained by finger prick the ghrelin plasma concentration will be determined using a Bioplex assay. The ghrelin plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Measured: During the taVNS intervention (30 min).
Change in Ghrelin Plasma Concentration induced by sham taVNS
Using capillary blood samples obtained by finger prick the ghrelin plasma concentration will be determined using a Bioplex assay. The ghrelin plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Measured: During the taVNS intervention (30 min).
Change in Leptin Plasma Concentration induced by taVNS
Using capillary blood samples obtained by finger prick the leptin plasma concentration will be determined using a Bioplex assay. The leptin plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Measured: During the taVNS intervention (30 min).
Change in Leptin Plasma Concentration induced by sham taVNS
Using capillary blood samples obtained by finger prick the leptin plasma concentration will be determined using a Bioplex assay. The leptin plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Measured: During the taVNS intervention (30 min).
Change in PAI-1 Plasma Concentration induced by taVNS
Using capillary blood samples obtained by finger prick the PAI-1 plasma concentration will be determined using a Bioplex assay. The PAI-1 plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Measured: During the taVNS intervention (30 min).
Change in PAI-1 Plasma Concentration induced by sham taVNS
Using capillary blood samples obtained by finger prick the PAI-1 plasma concentration will be determined using a Bioplex assay. The PAI-1 plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Measured: During the taVNS intervention (30 min).
Change in Resistin Plasma Concentration induced by taVNS
Using capillary blood samples obtained by finger prick the resistin plasma concentration will be determined using a Bioplex assay. The resistin plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Measured: During the taVNS intervention (30 min).
Change in Resistin Plasma Concentration induced by sham taVNS
Using capillary blood samples obtained by finger prick the resistin plasma concentration will be determined using a Bioplex assay. The resistin plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Measured: During the taVNS intervention (30 min).
Change in Vistatin Plasma Concentration induced by taVNS
Using capillary blood samples obtained by finger prick the vistatin plasma concentration will be determined using a Bioplex assay. The vistatin plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Measured: During the taVNS intervention (30 min).
Change in Vistatin Plasma Concentration induced by sham taVNS
Using capillary blood samples obtained by finger prick the vistatin plasma concentration will be determined using a Bioplex assay. The vistatin plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Measured: During the taVNS intervention (30 min).
Change in Adipsin Plasma Concentration induced by taVNS
Using capillary blood samples obtained by finger prick the adipsin plasma concentration will be determined using a Bioplex assay. The adipsin plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Measured: During the taVNS intervention (30 min).
Change in Adipsin Plasma Concentration induced by sham taVNS
Using capillary blood samples obtained by finger prick the adipsin plasma concentration will be determined using a Bioplex assay. The adipsin plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Measured: During the taVNS intervention (30 min).
Change in Adiponectin Plasma Concentration induced by taVNS
Using capillary blood samples obtained by finger prick the adipsin plasma concentration will be determined using a Bioplex assay. The adiponectin plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Measured: During the taVNS intervention (30 min).
Change in Adiponectin Plasma Concentration induced by sham taVNS
Using capillary blood samples obtained by finger prick the adipsin plasma concentration will be determined using a Bioplex assay. The adiponectin plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Measured: During the taVNS intervention (30 min).
Secondary outcomes (2)
Changes in Autonomic Function induced by taVNS
Autonomic function will be assessed by heart rate variability analysis of ECG recordings obtained before and after application of taVNS. Changes in autonomic function will be determined by the difference in heart rate variability before and after taVNS (after taVNS minus before taVNS).
Measured: During the taVNS intervention (30 min).
Changes in Autonomic Function induced by sham taVNS
Autonomic function will be assessed by heart rate variability analysis of ECG recordings obtained before and after application of sham taVNS. Changes in autonomic function will be determined by the difference in heart rate variability before and after sham taVNS (after sham taVNS minus before sham taVNS).
Measured: During the sham taVNS intervention (30 min).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start14 Jun 2021
- Primary completion26 Apr 2022
- Study completion26 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Research participants in three groups (normal weight, overweight, obese) will undergo 2 study days (at least one week apart) during which either transcutaneous auricular vagus nerve stimulation (taVNS) or a sham procedure will be performed. The order of the intervention (taVNS or sham procedure) on the two study days is randomized.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burrell College of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harald Stauss, Burrell College of Health Sciences
- Investigators
- Harald M Stauss, MD, PhD, Principal investigator, Burrell College of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926415
- Sponsor's protocol ID
- 0079_2021
- Status last verified
- Apr 2022
- First submitted
- 2 Jun 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Obesity and Insulin Resistance
- ClinicalTrials.gov ID
- NCT04926415
- Acronym / sponsor ID
- 0079_2021
- Conditions
- Diabetes Mellitus, Type 2, Obesity
- Keywords
- insulin resistance, blood glucose, insulin, glucagon, C-peptide, GLP-1, GIP, ghrelin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Burrell College of Health SciencesUniversity, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 26 Apr 2022 (actual)
- Study completion
- 26 Apr 2022 (actual)
- First posted
- 15 Jun 2021 (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.
Being overweight or obese has been associated with insulin resistance contributing to an increased risk for the development of type II diabetes. Food intake, metabolic rate, and blood glucose levels are regulated by the autonomic nervous system, including the vagus nerve. This study evaluates the hypothesis that non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) affects hormones that regulate food intake and blood glucose levels in a way that is consistent with reduced food intake and lower blood glucose levels. The investigators further hypothesize that these effects of taVNS depend on body weight. In a cross-over design generally healthy study participants will receive either taVNS or a sham intervention for 30 minutes on two separate study days. The order of the intervention on the two study days will be randomized and the two study days are at least one week apart. Based on body mass index (BMI) study participants are assigned to either a normal weight (BMI<25), overweight (BMI<30), or obese (BMI>30) group. Capillary blood samples taken by finger prick before and after the intervention on each study day will be analyzed for blood glucose concentration and hormones that are linked to food intake and blood glucose levels. In addition, autonomic function will be assessed by heart rate variability analysis of ECG recordings obtained before, during, and after the intervention on each study day.
Detailed description
Clinical studies and experimental studies in animals have demonstrated that cervical vagus nerve stimulation causes weight loss in obese patients and has profound effects on glucose homeostasis. Furthermore, anorexic and antidiabetic effects have been reported in response to non-invasive transcutaneous auricular vagus nerve stimulation (taVNS). Thus, non-invasive taVNS may potentially prevent insulin resistance in obesity. The objective of this study is to investigate the acute effects of taVNS on hormones and adipokines linking obesity with insulin resistance in human subjects. The hypothesis of this study is that acute application of taVNS elicits anti-diabetic effects through modulation of plasma levels of insulin, glucagon, C-peptide, GLP-1 (stimulates insulin and suppresses glucagon release), and GIP (gastric inhibitory polypeptide, stimulates insulin secretion). Furthermore, the investigators hypothesize that taVNS elicits anorexic effects by modulating ghrelin and leptin plasma levels. Finally the investigators hypothesize that taVNS may reduce the impact of obesity on insulin resistance by modulating PAI-1 (plasminogen activator inhibitor-1; increased in obesity and metabolic syndrome), resistin (adipose tissue secretory factor, suggested to link obesity with insulin resistance), vistatin (enriched in visceral fat and may stimulate the insulin receptor), adipsin (secreted from adipocytes; improves β-cell function), and adiponectin (secreted from adipose tissue; increases insulin sensitivity). In normal weight (BMI<25, n=14), overweight (BMI<30, n=14), and obese (BMI>30, n=14) and otherwise healthy study participants blood glucose levels and plasma concentrations (finger prick blood sampling) of insulin, glucagon, C-peptide, GLP-1, GIP, ghrelin, leptin, PAI-1, resistin, vistatin (Bio-Plex kit 171A7001M), adipsin, and adiponectin (Bio-Plex kit 171A7002M) will be determined before and after 30 minutes of taVNS (EMS 7500, 10 Hz, 300ms, n=7 in each body weight group) or sham taVNS (control experiment, n=7 in each body weight group). Before, during and after taVNS or sham taVNS autonomic function will be assessed by heart rate variability analysis from ECG recordings. The investigators expect that the outcome of this study will demonstrate that taVNS lowers blood glucose levels and elicits hormone/adipokine responses consistent with anorexia and improved insulin resistance. The investigators further hypothesize that these effects of taVNS will be more pronounced in obese compared to overweight and normal weight study participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Research participants in three groups (normal weight, overweight, obese) will undergo 2 study days (at least one week apart) during which either transcutaneous auricular vagus nerve stimulation (taVNS) or a sham procedure will be performed. The order of the intervention (taVNS or sham procedure) on the two study days is randomized.
| Arm | Type | Receives |
|---|---|---|
| Normal Weight | Experimental | Device: taVNS, Device: Sham taVNSThis arm consists of study participants with a body mass index (BMI) of less than 25. These study participants will participate on two study days. On one study day non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) and on the other study day a sham procedure will be performed. Capillary blood samples (finger prick) will be obtained before and after the interventions on both study days. The ECG will be recorded before, during, and after the intervention on both study days. |
| Overweight | Experimental | Device: taVNS, Device: Sham taVNSThis arm consists of study participants with a body mass index (BMI) of more than 25 but less than 30. These study participants will participate on two study days. On one study day non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) and on the other study day a sham procedure will be performed. Capillary blood samples (finger prick) will be obtained before and after the interventions on both study days. The ECG will be recorded before, during, and after the intervention on both study days. |
| Obese | Experimental | Device: taVNS, Device: Sham taVNSThis arm consists of study participants with a body mass index (BMI) of more than 30. These study participants will participate on two study days. On one study day non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) and on the other study day a sham procedure will be performed. Capillary blood samples (finger prick) will be obtained before and after the interventions on both study days. The ECG will be recorded before, during, and after the intervention on both study days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Generally healthy
Key exclusion criteria (13 listed)
- Age under 18 years
- Pregnancy
- Acute illnesses/fever
- Any medication that interferes with the autonomic nervous system (e.g., beta blockers)
- Any medication that interferes with glucose metabolism (e.g., antidiabetic drugs)
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 |
|---|---|---|
| taVNSAlso: Transcutaneous Auricular Vagus Nerve StimulationA bipolar clip electrode is attached to the auricle at the location of the cymba conchae. Electrical stimulation (30 Hz stimulation frequency, 300 μs pulse width) is applied for 30 min. The stimulation current is determined individually for each participant by slowly increasing the stimulation current until the participants feel a mild tingling sensation at the site of the electrode. Then the current is gradually reduced until the tingling sensation disappears. This current will then be used for taVNS. A TENS 7000 or EMS 7500 device (510(k): K080661) is used. | Device | Normal Weight, Obese, Overweight |
| Sham taVNSAlso: Sham Transcutaneous Auricular Vagus Nerve StimulationA bipolar clip electrode is attached to the auricle at the location of the cymba conchae but no electrical current is applied to the electrode. | Device | Normal Weight, Obese, Overweight |
Primary outcome
Change in Blood Glucose Concentration induced by taVNS
Time frame: During the taVNS intervention (30 min).
The blood glucose concentration is measured before and after application of taVNS from capillary blood samples obtained by finger prick. The change in blood glucose concentration is determined as the difference in the two blood glucose concentrations (after taVNS minus before taVNS).
Change in Blood Glucose Concentration induced by sham taVNS
Time frame: During the sham taVNS intervention (30 min).
The blood glucose concentration is measured before and after application of sham taVNS from capillary blood samples obtained by finger prick. The change in blood glucose concentration is determined as the difference in the two blood glucose concentrations (after sham taVNS minus before sham taVNS).
Change in Insulin Plasma Concentration induced by taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the insulin plasma concentration will be determined using a Bioplex assay. The insulin plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Change in Insulin Plasma Concentration induced by sham taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the insulin plasma concentration will be determined using a Bioplex assay. The insulin plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Change in Glucagon Plasma Concentration induced by taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the glucagon plasma concentration will be determined using a Bioplex assay. The glucagon plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Change in Glucagon Plasma Concentration induced by sham taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the glucagon plasma concentration will be determined using a Bioplex assay. The glucagon plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Change in C-Peptide Plasma Concentration induced by taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the C-peptide plasma concentration will be determined using a Bioplex assay. The C-peptide plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Change in C-Peptide Plasma Concentration induced by sham taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the C-peptide plasma concentration will be determined using a Bioplex assay. The C-peptide plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Change in GLP-1 Plasma Concentration induced by taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the GLP-1 plasma concentration will be determined using a Bioplex assay. The GLP-1 plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Change in GLP-1 Plasma Concentration induced by sham taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the GLP-1 plasma concentration will be determined using a Bioplex assay. The GLP-1 plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Change in GIP Plasma Concentration induced by taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the GIP plasma concentration will be determined using a Bioplex assay. The GIP plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Change in GIP Plasma Concentration induced by sham taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the GIP plasma concentration will be determined using a Bioplex assay. The GIP plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Change in Ghrelin Plasma Concentration induced by taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the ghrelin plasma concentration will be determined using a Bioplex assay. The ghrelin plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Change in Ghrelin Plasma Concentration induced by sham taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the ghrelin plasma concentration will be determined using a Bioplex assay. The ghrelin plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Change in Leptin Plasma Concentration induced by taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the leptin plasma concentration will be determined using a Bioplex assay. The leptin plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Change in Leptin Plasma Concentration induced by sham taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the leptin plasma concentration will be determined using a Bioplex assay. The leptin plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Change in PAI-1 Plasma Concentration induced by taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the PAI-1 plasma concentration will be determined using a Bioplex assay. The PAI-1 plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Change in PAI-1 Plasma Concentration induced by sham taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the PAI-1 plasma concentration will be determined using a Bioplex assay. The PAI-1 plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Change in Resistin Plasma Concentration induced by taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the resistin plasma concentration will be determined using a Bioplex assay. The resistin plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Change in Resistin Plasma Concentration induced by sham taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the resistin plasma concentration will be determined using a Bioplex assay. The resistin plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Change in Vistatin Plasma Concentration induced by taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the vistatin plasma concentration will be determined using a Bioplex assay. The vistatin plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Change in Vistatin Plasma Concentration induced by sham taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the vistatin plasma concentration will be determined using a Bioplex assay. The vistatin plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Change in Adipsin Plasma Concentration induced by taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the adipsin plasma concentration will be determined using a Bioplex assay. The adipsin plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Change in Adipsin Plasma Concentration induced by sham taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the adipsin plasma concentration will be determined using a Bioplex assay. The adipsin plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
Change in Adiponectin Plasma Concentration induced by taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the adipsin plasma concentration will be determined using a Bioplex assay. The adiponectin plasma concentration will be determined before and after application of taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after taVNS minus before taVNS).
Change in Adiponectin Plasma Concentration induced by sham taVNS
Time frame: During the taVNS intervention (30 min).
Using capillary blood samples obtained by finger prick the adipsin plasma concentration will be determined using a Bioplex assay. The adiponectin plasma concentration will be determined before and after application of sham taVNS and the change in plasma concentration will be determined as the difference in the plasma concentrations (after sham taVNS minus before sham taVNS).
2 secondary outcomes
Changes in Autonomic Function induced by taVNS
Time frame: During the taVNS intervention (30 min).
Changes in Autonomic Function induced by sham taVNS
Time frame: During the sham taVNS intervention (30 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 28 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Harald M Stauss, MD, PhD principal investigator
Burrell College of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing taVNS in people with Diabetes Mellitus, Type 2 and Obesity, run by Burrell College of Health Sciences at 1 site in United States.
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 1 inclusion and 13 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 28 Apr 2022. 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 United States. 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?
Change in Blood Glucose Concentration induced by taVNS (time frame: During the taVNS intervention (30 min).). The study lists 26 primary outcomes in all. 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 28 Apr 2022.