Effect of Vestibular Nerve Stimulation in Type 2 Diabetes Mellitus

Name of Study

Effect of Vestibular Nerve Stimulation in Type 2 Diabetes Mellitus.

Purpose of Study (300 words)

There is an ongoing and worsening problem with type 2 diabetes in much of the developing world. There is a growing realisation that that exposure to diets rich in sugar and fat, particularly in childhood, can damage the part of the brain that determines how much fat there is in the body. This may play a role in the development of metabolic syndrome, type 2 diabetes and poor glycaemic control. Animal and human studies suggest that a non-invasive neurological process called Vestibular Nerve Stimulation (VeNS) pushes the body’s set- point for fat downwards resulting in 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 diabetic outcomes such as glycaemic control. The purpose of this study is to evaluate the effectiveness of VeNS, together with a lifestyle modification program (hypocaloric diet) as a method of treating type 2 diabetes mellitus.

Type of Study (observational/exploratory etc)

Randomised double blind sham controlled clinical trial.

Are you recruiting participants for this trial?

Yes

State geographical location of study (city/county/country) (single or multiple sites)

Dublin

Who can take part?

Non-smoking adults who have type 2 diabetes, HbA1c between 7-9.5% (53-80mmol/mol), on stable anti-diabetic medication (no more than two) for at least 90 days and are not taking insulin. Must be willing to travel to Dublin 3 (possibly 4 for additional screening visit) times over 6 months.

What will the participants be asked to do? (max 300 words)

This is a 24-week study which requires three visits to the St. Vincent’s Hospital in Dublin at the following time points: baseline (week 0), week 12 and week 24.

During the first visit you will receive study materials including the Vestibular Nerve Stimulation device (a headset that clips behind the ear using sticky pads) and an iPod that links to the device.

During the study visits you will have several measurements taken including a blood draw, height, weight, body composition and hip and waist measurements and a range of questionnaires.

You will be required to use the device for an hour a day for the duration of the study.

You may also receive dietary counselling during your first and second visit from a dietician/or nutritionist and be required to follow a diet (500 kcal per day less than current diet) for the duration of the study. You will be required to engage with a dedicated clinical trial mentor once a week (by means of a 10-minute call) for the duration of the study.

You will be compensated for any travel to the site.

Recruitment Start Date

21/05/2021

Recruitment Finish Date

23/12/2021

Study Duration

24 weeks

This study is funded by:

Neurovalens Ltd.

For further information contact:

[email protected]

Phone