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Type 2 DiabetesNCT04149951

Effect of VeSTAL Device in Type 2 Diabetes Mellitus

A study testing Vestal Device in people with Type 2 Diabetes and Metabolic Syndrome, run by Neurovalens Ltd. at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS), together with a lifestyle modification program, as a method of reducing HbA1c, as compared to a sham control with both study arms incorporating a lifestyle modification program. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Type 2 Diabetes, Metabolic Syndrome
What is being tested?
Vestal Device
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteIreland
Study dates
3 Jun 2020to 22 Jan 2021
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 DM
  • HbA1c ≥7.0% and ≤10.0%
  • If on oral anti-diabetic medication should be stable dosage regime last 3 months
  • Males or Females. Note females of child-bearing potential must have a negative urine pregnancy test.
  • 18-80 years of age inclusive on starting the study.
  • Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with: trying to use the device on a daily basis; the hypocaloric diet weight loss program; and this provided weight loss support and mentoring.
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  • Agreement not to use of prescription, or over-the-counter, weight loss preparations for the duration of the trial.
  • Agreement not to start smoking tobacco or marijuana for the duration of the study.
  • Access to Wi-Fi (to connect iPod to internet)

Who cannot join

  • History of vestibular dysfunction or other inner ear disease as indicated by the screening questions.
  • History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
  • History of weight loss device implantation (e.g. VBloc Maestro or Abiliti).
  • Use of a non-invasive weight loss device (e.g. Modius)
  • Hypothyroidism requiring current treatment with levothyroxine (e.g. Levo-T, Synthroid, Thyroxine) (Other thyroid disorder patients on stable treatment for at least 3 months are acceptable).
  • Other endocrinological causes of weight gain (e.g. Cushing's disease, Cushing's syndrome or acromegaly)
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  • Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working).
  • Diagnosis of liver, kidney or heart failure.
  • Tobacco or marijuana smoking in the 3 months before starting and for the duration of the study.
  • Known genetic cause of type 2 DM (e.g., Prader-Willi Syndrome).
  • Current, active member of an organized weight loss program.
  • Diagnosis of Type 1 DM.
  • Use of insulin.
  • Diagnosis of epilepsy or use of anti-epileptic medication within 3 months of starting the study (e.g. for the treatment of peripheral neuropathy)
  • Use of oral or intravenous corticosteroid medication within 3 months of starting the study.
  • Use of the beta-blockers within 3 months of starting the study.
  • Current alterations in treatment regimens of anti-depressant medication for whatever reason (including tricyclic antidepressants) (Note: stable treatment regimen for prior 6 months acceptable).
  • A myocardial infarction within the preceding year.
  • A history of stroke or severe head injury (as defined by a head injury that required craniotomy or endotracheal intubation). (In case this damaged the neurological pathways involved in vestibular stimulation).
  • Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).
  • Untreated severe depression, schizophrenia, substance abuse, and eating disorder.
  • Current participant in another clinical trial.
  • Have a family member who is currently participating or is planning to participate in this study.
  • Pregnancy.
  • Blood transfusion within 4 months, or need for recurrent transfusions.
  • Hemolytic anemias including sickle cell, thalassemia and autoimmune varieties.
  • Hemochromatosis.
  • Use of dietary/ herbal supplements to assist with diabetic control.
  • History of migraine headaches.

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • St Vincents Hospital

    Dublin

Other trials in Ireland

About this study

Official title: Randomized, Double Blind Controlled Trial to Evaluate Efficacy of Vestibular Nerve Stimulation (VeNS), With Lifestyle Modification, Compared to Control and Lifestyle Modification, as a Means of Lowering HbA1c in Adults With Type 2 Diabetes

The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS), together with a lifestyle modification program, as a method of reducing HbA1c, as compared to a sham control with both study arms incorporating a lifestyle modification program.

  • Allocation: Randomized
  • Endpoint classification: Efficacy Study
  • Intervention Model: Parallel Assignment in 1:1 active to control allocation
Read the detailed description

There is an ongoing and worsening problem with type 2 diabetes mellitus (DM) in the developed, and much of the developing world. Although it has long been realized that Western diets that are rich in sugar and fat play an important role in this, it has only recently been realized that exposure to these diets, particularly in childhood, can damage the part of the brain that determines how much fat there is in the body, which may well play a role in the development of metabolic syndrome, deranged glycemic control and type 2 DM. It is believed, based on animal and human work, that VeNS pushes the set-point for fat downwards to cause fat loss, possibly because this indicates to the brain a state of increased physical activity. VeNS may additionally have other direct, yet to be quantified, effects on glycemic control.

The sponsors have unpublished pilot data from Dr Saisailesh Kumar at RDG Medical College in India that show an improvement in glycemic control can be achieved by one hour a day of VeNS over a three month period. Both groups received a hypocaloric diet tailored to diabetics. The aim of this study is to determine whether this effect can be replicated in a slightly larger European based population.

Being tested
Vestal Device, Placebo device
Medical subject headings
Diabetes Mellitus, Type 2, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vestal DeviceDevice

    Vestibular nerve stimulator

  • Placebo deviceDevice

    Sham nerve stimulator

Study groups in NCT04149951
Study groupRoleWhat they receive
ActiveExperimentalRandomized to active device use plus lifestyle modification (500kcal deficit hypocaloric diet and 150 min of exercise per week for each subject).
Receives: Device: Vestal Device
ControlPlacebo comparatorRandomized to sham device use plus lifestyle modification (500kcal deficit hypocaloric diet and 150 min of exercise per week for each subject).
Receives: Device: Placebo device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycated Hemoglobin (HbA1c)

    Percentage

    Measured: 4 months

Secondary outcomes (9)

  1. Difference in mean weight loss between the active-product and sham-treated groups.

    Grams

    Measured: 4 months

  2. Daily caloric intake

    Two day 24 hour recall

    Measured: 4 months

  3. Blood pressure

    mmHg

    Measured: 4 months

  4. Waist circumference

    cm

    Measured: 4 months

  5. Hip circumference

    cm

    Measured: 4 months

  6. Body mass index

    kg/m2

    Measured: 4 months

  7. Appetite

    Rating from -1 to 1

    Measured: 4 months

  8. Cravings

    Rating from -1 to 1

    Measured: 4 months

  9. Fullness

    Rating from -1 to 1

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2019
  2. Study start3 Jun 2020
  3. Primary completion22 Jan 2021
  4. Study completion22 Jan 2021

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment in 1:1 active to control allocation
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04149951
Sponsor's protocol ID
UCD2
Status last verified
Jan 2024
First submitted
31 Oct 2019
Last updated
16 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Vestal Device in people with Type 2 Diabetes and Metabolic Syndrome, run by Neurovalens Ltd. at 1 site in Ireland.

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 9 inclusion and 29 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 16 Jan 2024. 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 Ireland. 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?

Glycated Hemoglobin (HbA1c) (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04149951.

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 16 Jan 2024.

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