Diabetes Mellitus, Type 2NCT04094649
Acute Study of Effect of Ultrasound Vagus Nerve Stimulation on Glycemia
A study testing Ultrasound Vagus Nerve Stimulation (DECIMA) in people with Diabetes Mellitus, Type 2, run by Aucta Technologies, Inc. at 1 site in United States.
Trial summary
This is an early feasibility study to evaluate the proof of concept of modulation of glycemia by non-invasive ultrasound vagus nerve stimulation. This protocol is exploratory in nature, therefore it is not intended to capture statistically valid results or test statistical hypotheses. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Ultrasound Vagus Nerve Stimulation (DECIMA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to Jul 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Written informed consent prior to any of the screening procedures
- Willingness to comply with all study procedures and available for the duration of the study
- Male or female age between 21 and 60 years old, inclusive
- Diabetes Mellitus Type 2 for at least 1 year
Who cannot join
- HbA1c greater than 10.5%
- Medical treatment regimen with insulin
- Medical treatment with antiinflammatory drugs such as Disease-Modifying Antirheumatic Drugs (DMARDs), i.e. Methotrexate and Cytokine-inhibitors, e.g. Adalimumab, and Etanercept.
- Clinically significant neuropathy in the opinion of the investigator or as documented in the subject's medical history
- Abundant fat tissue in neck, as evidenced by a neck circumference of more than 20''
- Clinically significant surgical procedure(s) or skin lesion(s) in neck that would affect subject safety or placement of device
Show all 18Show fewer
- Prior vagotomy
- History of clinically significant vasovagal syncope or presyncope
- Use of electrically active implanted medical device
- History of heat stroke or any heat intolerance that is deemed clinically significant in the opinion of the investigator
- History of renal dysfunction or a glomerulonephropathy defined as either nephritic or nephrotic syndrome, including estimated glomerular filtration rate of <30 mL/min
- Clinically significant cardiovascular condition or problem that in the opinion of the investigator would interfere with the study data or affect patient safety (e.g. uncontrolled hypertension, congestive heart failure, or documented evidence of prior coronary artery disease).
- Pregnancy or plans to become pregnant while participating in the study, as determined by urine pregnancy test conducted at the screening visit for women of childbearing potential. A woman of childbearing potential is defined as a premenopausal female capable of becoming pregnant. This includes women on oral, injectable, or mechanical contraception; women who are single; women whose husbands have been vasectomized or whose husbands have received or are utilizing mechanical contraceptive devices.
- Uncontrolled asthma or obstructive lung disease.
- History of sepsis
- Significant cardiac rhythm disturbances in the opinion of the investigator based on an ECG.
- GI surgery that could have lacerated any branch of the vagus nerve, i.e. cholecystectomy, gastrectomy, pancreatic surgery, etc.
- Other conditions that could impair the patient's ability to participate in the study according to the investigator's opinion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cognitive Clinical Trials, LLC
Scottsdale, Arizona, 85258
About this study
Official title: This is a Single-site, Double-blind, Randomized, Prospective, Sham-controlled, Crossover Early Feasibility Study to Determine Whether Ultrasound Vagus Nerve Stimulation (uVNS) Inhibits Postprandial Hyperglycemia in Humans
This is an early feasibility study to evaluate the proof of concept of modulation of glycemia by non-invasive ultrasound vagus nerve stimulation. This protocol is exploratory in nature, therefore it is not intended to capture statistically valid results or test statistical hypotheses. However, statistical analysis of the primary endpoint will be performed to allow more critical reflection of the data and to estimate the treatment effect for consider-ation in further studies.
Read the detailed description
The DECIMA device comprises an array of two focused ultra-sound applicators arranged with overlapping foci to deliver acoustic energy to a known focal depth within tissue. The focused ultrasound applicators are each comprised of an ultra-sound-emitting piezoelectric element coupled to a focusing lens. The array of the DECIMA device is coupled with an ultra-sound imaging system to locate the cervical vagus nerve, and a control system to deliver short bursts of ultrasound energy that are controlled by the operator in time and intensity.
The imaging system and the array of applicators are calibrated together, so the power is focused at a known location relative to the imaging system screen. Each focused applicator's lens is joined to an ultrasound coupling cylinder filled with water. Each coupling cylinder is lined with thin plastic film at the skin. The ultrasound output power of the applicators is monitored by each applicator's control unit which includes a display of the ultrasound intensity.
To perform ultrasound stimulation, ultrasound gel is placed on the skin over the nerve area in the neck. Then the coupling cylinders and imaging transducer are placed against the gel, then the DECIMA position is fixed in place by a support arm.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Ultrasound Vagus Nerve Stimulation (DECIMA)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Vagus Nerve Stimulation (DECIMA)Device
This is a single-site, double-blind, randomized, prospective, sham-controlled, crossover early feasibility study to determine whether ultrasound Vagus Nerve Stimulation (uVNS) inhibits postprandial hyperglycemia in humans.
| Study group | Role | What they receive |
|---|---|---|
| Sham vs Active Stimulation Positions | Sham comparator | Adults with Diabetes Mellitus Type 2 (DMT2) will be recruited and randomized to active uVNS or sham across two sessions according to a 2x2 crossover design. Sham uVNS will be delivered with the same stimulation parameters as active uVNS, but will be targeted to the left sternocleidomastoid muscle ~2 cm away from the vagus nerve. Receives: Device: Ultrasound Vagus Nerve Stimulation (DECIMA) |
| Active uVNS | Active comparator | Active stimulations will be targeted with the ultrasound beam of the DECIMA device .Active uVNS will be delivered to the left cervical vagus nerve following the OGTT through the 60-min time point. Receives: Device: Ultrasound Vagus Nerve Stimulation (DECIMA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood glucose Area Under the Curve (AUC, mg/dL ● hours) from baseline to 3 hours after an Oral Glucose Tolerance Test (OGTT) with Ultrasonic Vagus Nervous Stimulation (uVNS).hyperglycemia
The DECIMA device comprises an array of two focused ultra-sound applicators arranged with overlapping foci to deliver acoustic energy to a known focal depth within tissue.
Measured: Change from baseline in the 3-hour mean glucose AUC following an OGTT
Secondary outcomes (1)
Change in whole blood lipospolysaccharide-induced TNF-Alpha (pg/mL) production from base line to 4 hours post stimulation.
Inhibits postprandial hyperglycemia in patients with Diabetes Mellitus Type 2 via a temperature-medicated mechanism.
Measured: Change in mean Whole Blood Lipopolysaccharide-Induced TNF production from baseline to four (4) hours post-stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Aug 2019
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Why it stopped: Pending funding
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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a single-site, double-blind, randomized, prospective, sham-controlled, crossover early feasibility study to determine whether uVNS inhibits postprandial hyperglycemia in humans. Adults with DMT2 will be recruited and randomized to active uVNS or sham uVNS across two sessions according to a 2x2 crossover design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aucta Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- STATKING Clinical Services
- Responsible party
- Sponsor
- Investigators
- Albert Tejada, MD, PI, Principal investigator, Synexus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094649
- Sponsor's protocol ID
- AT-C-19-01
- Status last verified
- Jan 2021
- First submitted
- 6 Aug 2019
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- This is a Single-site, Double-blind, Randomized, Prospective, Sham-controlled, Crossover Early Feasibility Study to Determine Whether Ultrasound Vagus Nerve Stimulation (uVNS) Inhibits Postprandial Hyperglycemia in Humans
- ClinicalTrials.gov ID
- NCT04094649
- Acronym / sponsor ID
- AT-C-19-01
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Pending funding
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Aucta Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- STATKING Clinical Services
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 19 Sep 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.
This is an early feasibility study to evaluate the proof of concept of modulation of glycemia by non-invasive ultrasound vagus nerve stimulation. This protocol is exploratory in nature, therefore it is not intended to capture statistically valid results or test statistical hypotheses. However, statistical analysis of the primary endpoint will be performed to allow more critical reflection of the data and to estimate the treatment effect for consider-ation in further studies.
Detailed description
The DECIMA device comprises an array of two focused ultra-sound applicators arranged with overlapping foci to deliver acoustic energy to a known focal depth within tissue. The focused ultrasound applicators are each comprised of an ultra-sound-emitting piezoelectric element coupled to a focusing lens. The array of the DECIMA device is coupled with an ultra-sound imaging system to locate the cervical vagus nerve, and a control system to deliver short bursts of ultrasound energy that are controlled by the operator in time and intensity.
The imaging system and the array of applicators are calibrated together, so the power is focused at a known location relative to the imaging system screen. Each focused applicator's lens is joined to an ultrasound coupling cylinder filled with water. Each coupling cylinder is lined with thin plastic film at the skin. The ultrasound output power of the applicators is monitored by each applicator's control unit which includes a display of the ultrasound intensity.
To perform ultrasound stimulation, ultrasound gel is placed on the skin over the nerve area in the neck. Then the coupling cylinders and imaging transducer are placed against the gel, then the DECIMA position is fixed in place by a support arm.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a single-site, double-blind, randomized, prospective, sham-controlled, crossover early feasibility study to determine whether uVNS inhibits postprandial hyperglycemia in humans. Adults with DMT2 will be recruited and randomized to active uVNS or sham uVNS across two sessions according to a 2x2 crossover design.
| Arm | Type | Receives |
|---|---|---|
| Sham vs Active Stimulation Positions | Sham comparator | Device: Ultrasound Vagus Nerve Stimulation (DECIMA)Adults with Diabetes Mellitus Type 2 (DMT2) will be recruited and randomized to active uVNS or sham across two sessions according to a 2x2 crossover design. Sham uVNS will be delivered with the same stimulation parameters as active uVNS, but will be targeted to the left sternocleidomastoid muscle ~2 cm away from the vagus nerve. |
| Active uVNS | Active comparator | Device: Ultrasound Vagus Nerve Stimulation (DECIMA)Active stimulations will be targeted with the ultrasound beam of the DECIMA device .Active uVNS will be delivered to the left cervical vagus nerve following the OGTT through the 60-min time point. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Written informed consent prior to any of the screening procedures
- Willingness to comply with all study procedures and available for the duration of the study
- Male or female age between 21 and 60 years old, inclusive
- Diabetes Mellitus Type 2 for at least 1 year
Key exclusion criteria (18 listed)
- HbA1c greater than 10.5%
- Medical treatment regimen with insulin
- Medical treatment with antiinflammatory drugs such as Disease-Modifying Antirheumatic Drugs (DMARDs), i.e. Methotrexate and Cytokine-inhibitors, e.g. Adalimumab, and Etanercept.
- Clinically significant neuropathy in the opinion of the investigator or as documented in the subject's medical history
- Abundant fat tissue in neck, as evidenced by a neck circumference of more than 20''
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 |
|---|---|---|
| Ultrasound Vagus Nerve Stimulation (DECIMA)This is a single-site, double-blind, randomized, prospective, sham-controlled, crossover early feasibility study to determine whether ultrasound Vagus Nerve Stimulation (uVNS) inhibits postprandial hyperglycemia in humans. | Device | Active uVNS, Sham vs Active Stimulation Positions |
Primary outcome
Change in blood glucose Area Under the Curve (AUC, mg/dL ● hours) from baseline to 3 hours after an Oral Glucose Tolerance Test (OGTT) with Ultrasonic Vagus Nervous Stimulation (uVNS).hyperglycemia
Time frame: Change from baseline in the 3-hour mean glucose AUC following an OGTT
The DECIMA device comprises an array of two focused ultra-sound applicators arranged with overlapping foci to deliver acoustic energy to a known focal depth within tissue.
1 secondary outcome
Change in whole blood lipospolysaccharide-induced TNF-Alpha (pg/mL) production from base line to 4 hours post stimulation.
Time frame: Change in mean Whole Blood Lipopolysaccharide-Induced TNF production from baseline to four (4) hours post-stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
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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.
Albert Tejada, MD, PI principal investigator
Synexus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Vagus Nerve Stimulation (DECIMA) in people with Diabetes Mellitus, Type 2, run by Aucta Technologies, Inc. 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 4 inclusion and 18 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: paused, as of the sponsor's last update on 20 Aug 2021. 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. 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?
Results are not available in the source record.
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 Area Under the Curve (AUC, mg/dL ● hours) from baseline to 3 hours after an Oral Glucose Tolerance Test (OGTT) with Ultrasonic Vagus Nervous Stimulation (uVNS).hyperglycemia (time frame: Change from baseline in the 3-hour mean glucose AUC following an OGTT). 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 20 Aug 2021.