Clinical trial NCT02130401: Examining the Effects of Neuromodulation on Glucose Metabolism in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: neuromodulation
caloric vestibular stimulation
Type 2 Diabetes
Lead sponsor: Scion NeuroStim
Sponsor class: INDUSTRY
First posted: 2014-05-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is an open-label, proof of concept study with a single active treatment arm designed to assess whether CVS-based stimulation has a beneficial effect on patients with type 2 diabetes. The primary outcome measure is a difference between pre and post-treatment A1c.


Eligibility criteria: Inclusion Criteria

A subject is eligible for the study if all of the following criteria are met:

* Provide written informed consent prior to enrollment.
* Is male or female between 18-70 years old.
* Has been diagnosed with type II diabetes for greater than 12 months.
* Is currently either using lifestyle modification or taking one or two of the following oral antihyperglycemic agents and has been on stable doses for 90 days prior to screening:

  * metformin
  * DPP-4 inhibitors (sitagliptin, saxagliptin, alogliptin, linaglyptin)
  * Pioglitazone
* Has an A l c between 7.5 - 9.0% based upon point of care testing performed at visit 1.
* Currently performs self-monitoring blood glucose checks at least 3 times per week.
* Able to adhere to protocol requirements.

Exclusion Criteria

A subject will be excluded if any of the following criteria are met:

* Has Type 1 Diabetes or Gestational Diabetes.
* Is pregnant or planning to become pregnant during the course of the study.
* Current use OR use in the past 6 months of sulfonylureas.
* Current use OR use in the past 6 months of insulin
* History of cardiovascular disease or cerebrovascular disease.
* Any planned surgery during the course of the study.
* Current continuous renal replacement therapy.
* Current oral or injectable steroid use or use within the previous 3 months.
* Previous or current treatment with deep brain stimulation.
* Any previous known disease, injury, or surgical intervention involving the brain or central nervous system.
* Moderate or greater hearing loss.
* Presence of a cochlear implant.
* Diagnosed vestibular dysfunction.
* Eye surgery within the previous three months.
* Any history of previous ear surgery.
* Active ear infections or a perforated tympanic membrane.
* Presence of a serious or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

Primary outcomes:
measure: Measurement of Glycosylated Hemoglobin (A1c)
timeFrame: after 84 days of device use
Secondary outcomes:
measure: Measurement of Lipid Panel
timeFrame: after 84 days of device use
measure: Assessment of Quality of Life
timeFrame: after 84 days of device use
measure: Assessment of Mood
timeFrame: after 84 days of device use
measure: Assessment of Diabetes Related Self Care
timeFrame: after 84 days of device use
measure: Feasibility of the Device as an Intervention for the Diabetes Population
timeFrame: after 84 days of device use
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Highgate Specialty Center - UNC Diabetes Care Center
state: North Carolina
Study officials:
affiliation: Scion NeuroStim
name: Lesco Rogers, MD
role: STUDY_DIRECTOR
References: