This is an exploratory pilot study to assess the effects of hepatic ultrasound insonification on glucometabolic parameters in participants with Type 2 Diabetes through selective hepatic ultrasound of the porta hepatis region of the liver utilizing pulsed ultrasound.
This study requires a time commitment of up to 8 weeks, including screening, treatment, observation, and follow-up. There are 2 inpatient stays – one for 3 days and 2 nights and the second is for 4 days and 3 nights. There are also 3 outpatient visits, not including the screening visit. There is no study drug for this trial.
The purpose of this study is to evaluate the effect of liver ultrasound waves on changes from baseline in whole-body insulin sensitivity. This study will also test the safety and tolerability of liver ultrasound waves in participants with Type 2 Diabetes Mellitus, evaluate the effect of liver ultrasound waves on change from baseline in glucose tolerance and insulin secretion, and 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 approved specifically for use in people with diabetes. The use of the study device in this study is investigational and is considered a Non-Significant Risk (NSR). A NSR is one that does not meet the definition for a significant risk device.
- Male or Female:
- Between the ages of 21 and 75
- Diagnosed with Type 2 Diabetes for 1+ year
- BMI between 18-40
- HbA1c between 6.5%-10%
Study Participants may receive:
- Compensation of up to $2,323 if all visits are completed
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ProSciento’s clinical research facility is located 10 miles south of San Diego’s downtown area, 13 miles south of the San Diego International Airport, and 7 miles north of the US/Mexico border.
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