An Open-Label, Pilot Study to Assess the Effects of Hepatic Ultrasound Insonification on Glucometabolic Parameters in Subjects With T2DM

Detailed 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).

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