Clinical trial NCT04595968: Electrical Vestibular Nerve Stimulation (VeNS) Compared to Sham Control As a Means of Improving Glycemic Control in Adults with Type 2 Diabetes Mellitus
Official title: A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Vestibular Nerve Stimulation (VeNS), Together with a Lifestyle Modification Program, Compared to a Sham Control with a Lifestyle Modification Program, As a Means of Improving Glycemic Control in Adults with Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Neurovalens Ltd.
Sponsor class: INDUSTRY
Collaborators: name: University College Dublin
name: CS Lifescience
name: Clinical Trial Mentors
First posted: 2020-10-22
Enrollment: 267
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trial Title A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS), together with a lifestyle modification program, compared to a sham control with a lifestyle modification program, as a means of improving glycemic control in adults with type 2 diabetes mellitus.

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.

Allocation: Randomized to either active device or control device usage. All subjects will receive the same lifestyle advice.

Endpoint classification: Efficacy Study Intervention Model: Parallel Assignment in 1:1 active to control allocation Trial Participants: Those who have been diagnosed with Type 2 diabetes mellitus.

Planned Trial Period: The study will last 24 weeks in total for each subject. The primary analysis will be conducted at the 24 weeks timepoint.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
* Male or female, age ≥ 22 years and ≤ 70 years at the time of signing informed consent. (At the US sites). The non-US sites will recruit subjects aged ≥ 18 and ≤ 70 years.
* Diagnosed with Type 2 DM ≥ 90 days prior to day of enrolment
* HbA1c (glycated hemoglobin) ≥ 6.5 and ≤ 9.5% (48-80 mmol/mol) (both inclusive).
* If taking medication to treat diabetes, a stable dose of no more than 3 anti-diabetic medications for at least 90 days prior to enrolment.
* BMI ≥ 25 at non-US sites
* Must be under care of physician for follow-up of their type 2 DM (this can be a Primary Care Physician (PCP), endocrinologist or other hospitalist).
* Must agree to continue to participate with their routine diabetes care program.
* Access to Wi-Fi.

Exclusion Criteria:

* Diagnosis of Type 1 diabetes mellitus
* Diagnosis of diabetic neuropathy
* Diagnosis of diabetic nephropathy
* Diagnosis of retinopathy
* Skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears. Any disorder which in the investigator's opinion might jeopardize subject's safety or compliance with the protocol.
* Taking beta-blockers (if previously then can enroll if off ≥ 30 days).
* Taking insulin (if previously on insulin then should be off for ≥ 90 days prior to enrolment).
* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice)
* History of pancreatitis
* History of pancreatic surgery
* Hemochromatosis
* Either of the following within the previous year: myocardial infarction; or acute coronary syndrome.
* History of stroke
* History of epilepsy
* Splenectomy (due to effect on red blood cell turnover)
* History of anemia (if resolved for \> 90 days with treatment then can enroll)
* Blood transfusion within 90 days of enrolment (due to effect on HbA1c). (If transfusion occurs once enrolled then subject will be withdrawn).
* A diagnosis of a hemoglobinopathy (e.g. sickle cell disease and thalassemia, although those with sickle cell or thalassemic trait would be allowed to enroll);
* If on dietary supplements or herbal remedies, then if the subject is taking a preparation that might affect glycemic control they will be excluded. Specifically, subject will be excluded if taking biotin (vitamin B7); alpha-lipoic acid; chromium; herbal preparations marketed as being for diabetes.
* History of being diagnosed with renal, heart or liver failure
* History of active migraines with aura
* History of head injury requiring intensive care or neurosurgery.
* Change in diabetic medication within the last 90 days (prior to enrolment).
* Regular use (more than twice a month) of antihistamine medication within the last 6 months. Note: If the participant is taking Fexofenadine, they can be eligible for the trial. If the participant is on another anti-histamine medication they can voluntarily opt to switch to Fexofenadine and enrol in the trial after a washout period of 2 weeks.
* Current use of H2-receptior antagonist medication? (e.g., cimetidine, famotidine)
* History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)
* A diagnosis of myelofibrosis or a myelodysplastic syndrome.
* Previous use of Modius device
* Participation in other clinical trials sponsored by Neurovalens (e.g. Vestal study)
* Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.)
* Have a member of the same household who is currently participating in this study.
* History of vestibular dysfunction or other inner ear disease (as assessed on the screening questionnaire)
* Failure to pass the ATMAS Flex hearing test
* Failure to demonstrate a willingness for lifestyle modification (i.e diet and exercise) if BMI is ≥25 (as assessed on the screening questionnaire)
* Failure to agree to weekly engagements with the Clinical Trial Mentors during trial participation
* Failure to agree to use of device daily during trial participation (no more than 2 weeks usage drop without reasonable explanation)
* Use of any medication (e.g. hormonal modulators or corticosteroids) that could cause iatrogenic T2DM. (NB Topical steroid use is acceptable if judged by PI to be unrelated).
* Any other medical condition, or medication use, that in the opinion of the PI/CI is likely to make the subject refractory to VeNS.

Primary outcomes:
measure: Change in glycated hemoglobin (HbA1c)
timeFrame: 24 weeks
measure: Frequency of all device related Serious Adverse Events
timeFrame: 24 weeks
Secondary outcomes:
measure: Participants who achieve HbA1c targets
timeFrame: 24 weeks
measure: Change in Body weight
timeFrame: 24 weeks
measure: Reduction of HbA1c in relation to weight loss
timeFrame: 24 weeks
measure: Change in BMI
timeFrame: 24 weeks
measure: Change in waist-hip ratio (WHR)
timeFrame: 24 weeks
measure: Change in body composition (DXA scan)
timeFrame: 24 weeks
measure: Change in atherogenic index
timeFrame: 24 weeks
measure: Change in Total Cholesterol
timeFrame: 24 weeks
measure: Change in High Density Lipoprotein (HDL)
timeFrame: 24 weeks
measure: Change in Low Density Lipoprotein (LDL)
timeFrame: 24 weeks
measure: Change in Triglycerides
timeFrame: 24 weeks
measure: Change in Very-low-density lipoprotein (VLDL)
timeFrame: 24 weeks
measure: Change in pulse rate
timeFrame: 24 weeks
measure: Change in Mean arterial pressure (MAP)
timeFrame: 24 weeks
measure: Change in fasting plasma glucose
timeFrame: 24 weeks
measure: Change in 7 point Self Measured Blood Glucose (SMBG)
timeFrame: 24 weeks
measure: Change in anti-diabetic medication
timeFrame: 24 weeks
measure: Change in cardiovascular medication
timeFrame: 24 weeks
measure: Change in audit of diabetes dependent Quality of Life (QoL) score
timeFrame: 24 weeks
measure: Tolerability of treatment
timeFrame: 24 weeks
measure: Change in healthcare resource use
timeFrame: 24 weeks
measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)
timeFrame: 24 weeks
measure: Change in EQ-5D-5L
timeFrame: 24 weeks
measure: Frequency of Adverse Events (AEs)
timeFrame: 24 weeks
measure: Frequency of hypoglycemic episodes
timeFrame: 24 Weeks
measure: Frequency of episodes resulting with HbA1c > 10%
timeFrame: 24 weeks
measure: Change in hearing by means of AMTAS flex device
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: La Jolla
country: United States
facility: UC San Diego, Exercise and Physical Activity Resource Center
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: Hollywood
country: United States
facility: New Med Research
state: Florida
city: Medley
country: United States
facility: South Florida Research Organization
state: Florida
city: Mount Dora
country: United States
facility: Adult Medicine of Lake County
state: Florida
city: Oviedo
country: United States
facility: Oviedo Medical Research
state: Florida
city: Methuen
country: United States
facility: ActivMed Practices & Research
state: Massachusetts
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Las Vegas
country: United States
facility: Palm Research Center
state: Nevada
city: Portsmouth
country: United States
facility: ActivMed Practices & Research
state: New Hampshire
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Nashville
country: United States
facility: Complete Health Partners
state: Tennessee
city: McAllen
country: United States
facility: Biopharma Informatic
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center
state: Virginia
city: Dublin
country: Ireland
facility: St. Vincent's University Hospital
Study officials:
affiliation: UC San Diego
name: Erik Viirre, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: