This is a Single-site, Double-blind, Randomized, Prospective, Sham-controlled, Crossover Early Feasibility Study to Determine Whether Ultrasound Vagus Nerve Stimulation (uVNS) Inhibits Postprandial Hyperglycemia in Humans
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Aucta Technologies, Inc.
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Change in blood glucose Area Under the Curve (AUC, mg/dL ● hours) from baseline to 3 hours after an Oral Glucose Tolerance Test (OGTT) with Ultrasonic Vagus Nervous Stimulation (uVNS).hyperglycemia
- Status
- Suspended
- Last Updated
- 4 years ago
Overview
Brief Summary
This is an early feasibility study to evaluate the proof of concept of modulation of glycemia by non-invasive ultrasound vagus nerve stimulation. This protocol is exploratory in nature, therefore it is not intended to capture statistically valid results or test statistical hypotheses. However, statistical analysis of the primary endpoint will be performed to allow more critical reflection of the data and to estimate the treatment effect for consider-ation in further studies.
Detailed Description
The DECIMA device comprises an array of two focused ultra-sound applicators arranged with overlapping foci to deliver acoustic energy to a known focal depth within tissue. The focused ultrasound applicators are each comprised of an ultra-sound-emitting piezoelectric element coupled to a focusing lens. The array of the DECIMA device is coupled with an ultra-sound imaging system to locate the cervical vagus nerve, and a control system to deliver short bursts of ultrasound energy that are controlled by the operator in time and intensity. The imaging system and the array of applicators are calibrated together, so the power is focused at a known location relative to the imaging system screen. Each focused applicator's lens is joined to an ultrasound coupling cylinder filled with water. Each coupling cylinder is lined with thin plastic film at the skin. The ultrasound output power of the applicators is monitored by each applicator's control unit which includes a display of the ultrasound intensity. To perform ultrasound stimulation, ultrasound gel is placed on the skin over the nerve area in the neck. Then the coupling cylinders and imaging transducer are placed against the gel, then the DECIMA position is fixed in place by a support arm.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent prior to any of the screening procedures
- •Willingness to comply with all study procedures and available for the duration of the study
- •Male or female age between 21 and 60 years old, inclusive
- •Diabetes Mellitus Type 2 for at least 1 year
Exclusion Criteria
- •HbA1c greater than 10.5%
- •Medical treatment regimen with insulin
- •Medical treatment with antiinflammatory drugs such as Disease-Modifying Antirheumatic Drugs (DMARDs), i.e. Methotrexate and Cytokine-inhibitors, e.g. Adalimumab, and Etanercept.
- •Clinically significant neuropathy in the opinion of the investigator or as documented in the subject's medical history
- •Abundant fat tissue in neck, as evidenced by a neck circumference of more than 20''
- •Clinically significant surgical procedure(s) or skin lesion(s) in neck that would affect subject safety or placement of device
- •Prior vagotomy
- •History of clinically significant vasovagal syncope or presyncope
- •Use of electrically active implanted medical device
- •History of heat stroke or any heat intolerance that is deemed clinically significant in the opinion of the investigator
Outcomes
Primary Outcomes
Change in blood glucose Area Under the Curve (AUC, mg/dL ● hours) from baseline to 3 hours after an Oral Glucose Tolerance Test (OGTT) with Ultrasonic Vagus Nervous Stimulation (uVNS).hyperglycemia
Time Frame: Change from baseline in the 3-hour mean glucose AUC following an OGTT
The DECIMA device comprises an array of two focused ultra-sound applicators arranged with overlapping foci to deliver acoustic energy to a known focal depth within tissue.
Secondary Outcomes
- Change in whole blood lipospolysaccharide-induced TNF-Alpha (pg/mL) production from base line to 4 hours post stimulation.(Change in mean Whole Blood Lipopolysaccharide-Induced TNF production from baseline to four (4) hours post-stimulation)