Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04502212
Status:
COMPLETED
Last Update Posted:
2022-06-02
First Post:
2020-07-29
Brief Title:
Pilot Study to Assess the Effects of Hepatic Ultrasound Insonification on Subjects With T2DM
Sponsor:
General Electric Research
Organization:
General Electric Research
Study Overview
Official Title:
An Open-Label Pilot Study to Assess the Effects of Hepatic Ultrasound Insonification on Glucometabolic Parameters in Subjects With T2DM
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Insonifyinsonification 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 bodys cells are in response to insulin
Glucose tolerance refers to the bodys 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
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 bodys cells are in response to insulin
Glucose tolerance refers to the bodys 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 350 and 400 kgm2 andor 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
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 350 and 400 kgm2 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None