Acute Study of Effect of Ultrasound Vagus Nerve Stimulation on Glycemia

NCT04094649 | Suspended FDA Device

• 1 other identifier: AT-C-19-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Change from baseline in the 3-hour mean glucose AUC following an OGTT

Secondary Outcomes (1)

• 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

Study Arms (2)

Sham vs Active Stimulation Positions

SHAM COMPARATOR

Adults with Diabetes Mellitus Type 2 (DMT2) will be recruited and randomized to active uVNS or sham across two sessions according to a 2x2 crossover design. Sham uVNS will be delivered with the same stimulation parameters as active uVNS, but will be targeted to the left sternocleidomastoid muscle \~2 cm away from the vagus nerve.

Device: Ultrasound Vagus Nerve Stimulation (DECIMA)

Active uVNS

ACTIVE COMPARATOR

Active stimulations will be targeted with the ultrasound beam of the DECIMA device .Active uVNS will be delivered to the left cervical vagus nerve following the OGTT through the 60-min time point.

Device: Ultrasound Vagus Nerve Stimulation (DECIMA)

Interventions

Ultrasound Vagus Nerve Stimulation (DECIMA) DEVICE

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.

Active uVNS; Sham vs Active Stimulation Positions

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• History of renal dysfunction or a glomerulonephropathy defined as either nephritic or nephrotic syndrome, including estimated glomerular filtration rate of \<30 mL/min
• Clinically significant cardiovascular condition or problem that in the opinion of the investigator would interfere with the study data or affect patient safety (e.g. uncontrolled hypertension, congestive heart failure, or documented evidence of prior coronary artery disease).
• Pregnancy or plans to become pregnant while participating in the study, as determined by urine pregnancy test conducted at the screening visit for women of childbearing potential. A woman of childbearing potential is defined as a premenopausal female capable of becoming pregnant. This includes women on oral, injectable, or mechanical contraception; women who are single; women whose husbands have been vasectomized or whose husbands have received or are utilizing mechanical contraceptive devices.
• Uncontrolled asthma or obstructive lung disease.
• History of sepsis

Sponsors & Collaborators

• Aucta Technologies, Inc.: lead
• STATKING Clinical Services: collaborator

Study Sites (1)

Cognitive Clinical Trials, LLC

Scottsdale, Arizona, 85258, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Albert Tejada, MD, PI

  Synexus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomization will be assigned by the clinical research facility. One of the two experimenters will be blinded. The unblinded experimenter is needed to aim the stimulation to the vagus nerve or sham location. The blinded experimenter will acquire, process, and analyze all data. Participants will be told that they may or may not feel the stimulation. The uVNS probe will be placed on their neck for each stimulation burst with the unblinded experimenter control-ling whether active or sham uVNS is delivered as determined by the crossover assignment.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single-site, double-blind, randomized, prospective, sham-controlled, crossover early feasibility study to determine whether uVNS inhibits postprandial hyperglycemia in humans. Adults with DMT2 will be recruited and randomized to active uVNS or sham uVNS across two sessions according to a 2x2 crossover design.

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: September 19, 2019
• Study Start: August 1, 2019
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: August 20, 2021

Record last verified: 2021-01

Locations

US (1)