Pilot Study to Assess the Effects of Hepatic Ultrasound Insonification on Subjects With T2DM
Condition: Type 2 Diabetes
Study type: Interventional

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).
    

Detailed description: 
      This was an open label, exploratory pilot study to assess the effects of hepatic ultrasound
      insonification on glucometabolic parameters in subjects with T2DM through selective hepatic
      ultrasound of the porta hepatis region of the liver utilizing pulsed ultrasound. The study
      was to consist of 1 cohort comprising up to 15 subjects. Dropouts and withdrawals could have
      been replaced until the anticipated number of subjects completed the study. Finally, the
      study consisted of one cohort with 36 subjects enrolled, including 20 screen failures, 15
      subjects that completed the study (1 completer had an incorrect infusion parameter and was
      removed from clamp analysis), and 1 subject that was discontinued at the discretion of the
      Investigator. As this was an exploratory, open-label study, no randomization or blinding was
      performed and no-unblinding codes were required.

      The study included a Screening Period, Observational Period 1, 3 consecutive days of hepatic
      ultrasound insonification, and Observational Period 2. Each Observational Period was divided
      into an In-house Period and an Outpatient Visit (OPV). The Screening Period was performed up
      to 28 days prior to the first In-house Period. For eligible subjects with a body mass index
      (BMI) > 35.0 and ≤ 40.0 kg/m2 and/or a waist circumference > 40 and ≤ 45 inches, an
      ultrasound examination was added to confirm eligibility, and the Screening Period was
      extended to at least 30 days. The first Observational Period lasted approximately 2-weeks
      (Days -1 to 14). On the morning of Day -1, subjects checked into the clinic for a 3-day
      In-house Period; subjects may have been released from the clinic on Day 2. Subjects were
      contacted via telephone every other day until the next In-house Period. On Day 8, subjects
      checked into the clinic for an OPV. On Day 15, subjects checked into the clinic in fasting
      conditions for a 4-day In-house Period. Insonifications were performed on three consecutive
      days (Days 15, 16 and 17). Subjects may have been released from the clinic on Day 18. The
      second Observational Period lasted 11 days (Days 18 to 28). Subjects were contacted via
      telephone every other day until the Follow-up Visit. On Day 22, subjects checked into the
      clinic for the OPV. The Follow-up Visit was performed on Day 28.
    

Intervention name(s): Hepatic Ultrasound Insonification
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other