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Acute Study of Effect of Ultrasound Vagus Nerve Stimulation on Glycemia

NCT04094649 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-08-20

No results posted yet for this study

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

Interventions

DEVICE

Ultrasound Vagus Nerve Stimulation (DECIMA)

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.

Sponsors & Collaborators

  • STATKING Clinical Services

    collaborator UNKNOWN

  • Aucta Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Albert Tejada, MD, PI · Synexus

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2022-07-31
Completion
2022-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04094649 on ClinicalTrials.gov