Effect of VeSTAL Device in Type 2 Diabetes Mellitus

NCT04149951 | Completed

• 1 other identifier: UCD2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Glycated Hemoglobin (HbA1c)

  Percentage

  4 months

Secondary Outcomes (9)

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

  4 months

• Daily caloric intake

  4 months

• Blood pressure

  4 months

• Waist circumference

  4 months

• Hip circumference

  4 months

Other Outcomes (2)

• Mentorship support usage

  4 months

• Dose response analysis

  4 months

Study Arms (2)

Active

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Vestal Device DEVICE

Vestibular nerve stimulator

Active

Placebo device DEVICE

Sham nerve stimulator

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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)

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Neurovalens Ltd.: lead
• Compliance Solutions Ltd.: collaborator
• University College Dublin: collaborator
• Exploristics Ltd: collaborator

Study Sites (1)

St Vincents Hospital

Dublin, Ireland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Study Officials

• Carel Le Roux, MD PhD

  UCD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment in 1:1 active to control allocation

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 4, 2019
• Study Start: June 3, 2020
• Primary Completion: January 22, 2021
• Study Completion: January 22, 2021
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)