Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-04 @ 8:55 AM
Study NCT ID:
NCT04149951
Status:
COMPLETED
Last Update Posted:
2024-01-16
First Post:
2019-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of VeSTAL Device in Type 2 Diabetes Mellitus
Sponsor:
Neurovalens Ltd.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* Allocation: Randomized
* Endpoint classification: Efficacy Study
* Intervention Model: Parallel Assignment in 1:1 active to control allocation
* Allocation: Randomized
* Endpoint classification: Efficacy Study
* Intervention Model: Parallel Assignment in 1:1 active to control allocation
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The sponsors have unpublished pilot data from Dr Saisailesh Kumar at RDG Medical College in India that show an improvement in glycemic control can be achieved by one hour a day of VeNS over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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: