Effect of VeSTAL Device in Type 2 Diabetes Mellitus

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

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Type 2 Diabetes
• Intervention / Treatment: Device: Vestal Device; Device: Placebo device

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The sponsors have unpublished pilot data from Dr Saisailesh Kumar at RDG Medical College in India that show an improvement in glycemic control can be achieved by one hour a day of VeNS over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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • St Vincents Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Type 2 DM
2. HbA1c ≥7.0% and ≤10.0%
3. If on oral anti-diabetic medication should be stable dosage regime last 3 months
4. Males or Females. Note females of child-bearing potential must have a negative urine pregnancy test.
5. 18-80 years of age inclusive on starting the study.
6. 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.
7. Agreement not to use of prescription, or over-the-counter, weight loss preparations for the duration of the trial.
8. Agreement not to start smoking tobacco or marijuana for the duration of the study.
9. Access to Wi-Fi (to connect iPod to internet)

Exclusion Criteria:

1. History of vestibular dysfunction or other inner ear disease as indicated by the screening questions.
2. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
3. History of weight loss device implantation (e.g. VBloc Maestro or Abiliti).
4. Use of a non-invasive weight loss device (e.g. Modius)
5. 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).
6. Other endocrinological causes of weight gain (e.g. Cushing's disease, Cushing's syndrome or acromegaly)
7. Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy which would prevent VeNS from working).
8. Diagnosis of liver, kidney or heart failure.
9. Tobacco or marijuana smoking in the 3 months before starting and for the duration of the study.
10. Known genetic cause of type 2 DM (e.g., Prader-Willi Syndrome).
11. Current, active member of an organized weight loss program.
12. Diagnosis of Type 1 DM.
13. Use of insulin.
14. Diagnosis of epilepsy or use of anti-epileptic medication within 3 months of starting the study (e.g. for the treatment of peripheral neuropathy)
15. Use of oral or intravenous corticosteroid medication within 3 months of starting the study.
16. Use of the beta-blockers within 3 months of starting the study.
17. Current alterations in treatment regimens of anti-depressant medication for whatever reason (including tricyclic antidepressants) (Note: stable treatment regimen for prior 6 months acceptable).
18. A myocardial infarction within the preceding year.
19. 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).
20. Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).
21. Untreated severe depression, schizophrenia, substance abuse, and eating disorder.
22. Current participant in another clinical trial.
23. Have a family member who is currently participating or is planning to participate in this study.
24. Pregnancy.
25. Blood transfusion within 4 months, or need for recurrent transfusions.
26. Hemolytic anemias including sickle cell, thalassemia and autoimmune varieties.
27. Hemochromatosis.
28. Use of dietary/ herbal supplements to assist with diabetic control.
29. History of migraine headaches.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; Randomized to active device use plus lifestyle modification (500kcal deficit hypocaloric diet and 150 min of exercise per week for each subject).	Device: Vestal Device; Vestibular nerve stimulator
Placebo Comparator: Control; Randomized to sham device use plus lifestyle modification (500kcal deficit hypocaloric diet and 150 min of exercise per week for each subject).	Device: Placebo device; Sham nerve stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycated Hemoglobin (HbA1c)	Percentage	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in mean weight loss between the active-product and sham-treated groups.	Grams	4 months
Daily caloric intake	Two day 24 hour recall	4 months
Blood pressure	mmHg	4 months
Waist circumference	cm	4 months
Hip circumference	cm	4 months
Body mass index	kg/m2	4 months
Appetite	Rating from -1 to 1	4 months
Cravings	Rating from -1 to 1	4 months
Fullness	Rating from -1 to 1	4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mentorship support usage	Average hours per week	4 months
Dose response analysis	Average hours per week	4 months

Collaborators and Investigators

• Sponsor: Neurovalens Ltd.
• Collaborators: University College Dublin; Exploristics Ltd; Compliance Solutions Ltd.
• Investigators: Principal Investigator: Carel Le Roux, MD PhD, UCD

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2020
• Primary Completion (Actual): January 22, 2021
• Study Completion (Actual): January 22, 2021

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Syndrome
• Other Study ID Numbers: UCD2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No