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
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 The sponsors have unpublished pilot data from Dr Saisailesh Kumar at RDG Medical College in India that show an improvement in glycemic control can be achieved by one hour a day of VeNS over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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Vestibular nerve stimulator
Sham nerve stimulator
St Vincents Hospital
Dublin, Ireland
Glycated Hemoglobin (HbA1c)
Percentage
Time frame: 4 months
Difference in mean weight loss between the active-product and sham-treated groups.
Grams
Time frame: 4 months
Daily caloric intake
Two day 24 hour recall
Time frame: 4 months
Blood pressure
mmHg
Time frame: 4 months
Waist circumference
cm
Time frame: 4 months
Hip circumference
cm
Time frame: 4 months
Body mass index
kg/m2
Time frame: 4 months
Appetite
Rating from -1 to 1
Time frame: 4 months
Cravings
Rating from -1 to 1
Time frame: 4 months
Fullness
Rating from -1 to 1
Time frame: 4 months
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