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Pilot Study to Assess the Effects of Hepatic Ultrasound Insonification on Subjects With T2DM

NCT04502212 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-06-02

Study results available
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Summary

This research study is being done to evaluate the effect of hepatic ultrasound insonification on whole-body insulin sensitivity and evaluate the safety and tolerability of hepatic ultrasound insonification in subjects with Type 2 Diabetes Mellitus (T2DM). "Insonify/insonification" is defined as applying to an area or an object carefully-controlled sound waves, typically as in ultrasound imaging. GE Research is sponsoring this research study. The purpose of this research study is to:

* Evaluate the effect of liver ultrasound waves on changes from baseline in whole-body insulin sensitivity
* Test the safety and tolerability of liver ultrasound waves in subjects with Type 2 Diabetes Mellitus
* Evaluate the effect of liver ultrasound waves on change from baseline in glucose tolerance and insulin secretion
* Evaluate the effect of liver ultrasound waves on glucose metabolism

Insulin sensitivity refers to how sensitive the body's cells are in response to insulin.

Glucose tolerance refers to the body's ability to handle (tolerate) glucose. Insulin secretion is a process in which the body releases insulin in response to glucose levels in the blood becoming elevated.

The study device used in this study is cleared for use by the United States Food and Drug Administration (FDA) for ultrasound diagnostic exams, however it has not been tested or approved specifically for modulation of metabolism in people with diabetes. The use of the study device in this study is investigational and is considered a Non-Significant Risk (NSR).

Conditions

Interventions

DEVICE

Hepatic Ultrasound Insonification

Hepatic ultrasound insonification will be performed after an overnight fast (no food or drinks except for water for at least 10 hours) at approximately the same time on each day for three days.

Sponsors & Collaborators

  • ProSciento, Inc.

    collaborator INDUSTRY

  • General Electric Research

    lead INDUSTRY

Principal Investigators

  • Bridgette Boggess Franey, MD · ProSciento, Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-07-30
Primary Completion
2021-05-24
Completion
2021-05-24
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04502212 on ClinicalTrials.gov