Evaluating the Efficacy of Electrical Vestibular Stimulation (VeNS), together with a lifestyle modification program, on Adults with Type 2 Diabetes Mellitus: Study Protocol of a Multicentre Double-Blinded, Randomized, Sham-Controlled Trial.

Abstract

Background Obesity and metabolic syndrome, including Type 2 Diabetes Mellitus (T2DM), are increasingly linked to neurological factors, influenced by lifestyle. Electrical Vestibular Nerve Stimulation (VeNS) has shown potential in improving metabolic factors in T2DM. However, no large-scale Randomized Controlled Trials (RCTs) have been conducted to assess VeNS's impact on T2DM management. Methods This double-blinded, sham-controlled RCT will compare the effects of active VeNS against sham VeNS over a 24-week period, with assessments at baseline, mid-intervention (12 weeks), and conclusion (24 weeks). The aim is to recruit 300 participants, aged 22–70 years (18–70 years in non-US sites) and diagnosed with T2DM for at least 90 days, who will be randomized into active (VeNs device) or control (sham device) groups in a 1:1 ratio. Participants will self-administer active VeNS or sham stimulation aiming for 1 hour daily (7 hours per week) over the 24 weeks. The primary objective is to evaluate changes in HbA1c (%) from baseline to week 24. Secondary objectives include assessing responder rates for HbA1c targets set by ADA and AACE, HbA1c reduction of at least 0.5%, changes in body weight, Body Mass Index (BMI), Waist-to-Hip Ratio (WHR), body composition, lipid profiles, pulse rate, blood pressure, fasting glucose, SMBG readings, medication adjustments, healthcare usage, and quality of life metrics (ADDQoL, EQ-5D-5L, DTSQ). Treatment tolerability will also be evaluated Discussion This study protocol presents an innovative approach to managing Type 2 Diabetes Mellitus (T2DM) by combining Electrical Vestibular Nerve Stimulation (VeNS) with a lifestyle modification program. The implications for clinical practice in T2DM management could be significant. The combination of VeNS with lifestyle modifications may offer a novel, non-pharmacological treatment avenue, potentially improving patient outcomes and reducing reliance on traditional medication regimes. Trial registration: ClinicalTrials.gov: NCT04595968. Registered 22 October 2020, https://clinicaltrials.gov/study/NCT04595968