Examining the Effects of Neuromodulation on Glucose Metabolism in Type 2 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Scion NeuroStim
Sponsor:
Information provided by (Responsible Party):
Scion NeuroStim
ClinicalTrials.gov Identifier:
NCT02130401
First received: April 30, 2014
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

This is a pilot study with a single active treatment arm. The study is designed to assess the efficacy of a portable, non-invasive neuromodulation system for the treatment of Type 2 Diabetes. In particular, the primary outcome measure is a reduction in A1c.


Condition Intervention
Type 2 Diabetes
Device: TNM (thermoneuromodulation device)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Device: Investigational Study to Examine the Effects of Neuromodulation on Glucose Metabolism in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Scion NeuroStim:

Primary Outcome Measures:
  • Measurement of glycosylated hemoglobin (A1c) [ Time Frame: after 84 days of device use ] [ Designated as safety issue: No ]
    At the end of the 84 day period of device use, the patient's A1c value will be compared with the baseline value to assess any reduction.


Secondary Outcome Measures:
  • Measurement of lipid panel [ Time Frame: after 84 days of device use ] [ Designated as safety issue: No ]
    At the end of the 84 day period of device use, the patient's fasting lipid panel will be taken and compared with the baseline panel to assess any difference in lipid metabolism.

  • Assessment of quality of life [ Time Frame: after 84 days of device use ] [ Designated as safety issue: No ]
    At the end of the 84 day period of device use, the patient's reports on quality of life measures will be compared with baseline values to assess any improvement.

  • Assessment of mood [ Time Frame: after 84 days of device use ] [ Designated as safety issue: No ]
    At the end of the 84 day period of device use, the patient's reports on mood measures will be compared with baseline values to assess any improvement.

  • Assessment of diabetes related self care [ Time Frame: after 84 days of device use ] [ Designated as safety issue: No ]
    At the end of the 84 day period of device use, the patient's reports on diabetes related self care will be compared with baseline values to assess any improvement.

  • Feasibility and acceptability of the device as an intervention for the diabetes population [ Time Frame: after 84 days of device use ] [ Designated as safety issue: Yes ]
    At the end of the 84 day period of device use, the patient will be asked to assess the device use experience and note any shortcomings, challenges or difficulties.


Estimated Enrollment: 15
Study Start Date: June 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TNM (thermoneuromodulation device)
A standardized active thermal neuromodulation waveform will be used for all patients. The device is non-invasive and does not use electrical stimulation.
Device: TNM (thermoneuromodulation device)
The device is worn like a music headset and the patient lies on a wedge pillow while the device is active. Each session lasts under 20 minutes.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
    • GLP-1 agonist (exenatide, liraglutide, exenatide LAR)
    • SGLT-2 Inhibitors (dapaglifozin, canagliflozin)
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02130401

Contacts
Contact: Robert D Black, Ph.D. 919 260-5528 bacllc@earthlink.net

Locations
United States, North Carolina
UNC Highgate Specialty Center - UNC Diabetes Care Center Recruiting
Chapel Hill, North Carolina, United States, 27713
Contact: Chandra Quigley, MA    919-957-5688 ext 274    chandra_quigley@med.unc.edu   
Contact: Laura Young, M.D., Ph.D.    919 484-1015    laura_young@med.unc.edu   
Principal Investigator: Laura Young, M.D., Ph.D.         
Sub-Investigator: John Buse, M.D., Ph.D.         
Sub-Investigator: Sue Kirkman, M.D.         
Sponsors and Collaborators
Scion NeuroStim
Investigators
Study Director: Lesco Rogers, MD Scion NeuroStim
  More Information

No publications provided

Responsible Party: Scion NeuroStim
ClinicalTrials.gov Identifier: NCT02130401     History of Changes
Other Study ID Numbers: SNS-DIA-01
Study First Received: April 30, 2014
Last Updated: June 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Scion NeuroStim:
neuromodulation
caloric vestibular stimulation
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 24, 2014