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Ultrasound Treatment for Insulin Sensitivity

N/A
Recruiting
Led By Raimund Herzog, MD, MHS
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Demonstration of abnormal glucose control and diagnosis of T2D according to current ADA criteria
Willingness to carry a continuous glucose monitor for at least 10 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during glucose tolerance testing (for 180 minutes).
Awards & highlights

Study Summary

This trial looks at how ultrasound treatment affects insulin sensitivity in the body.

Who is the study for?
This trial is for adults aged 18-80 with Type 2 diabetes who can consent and follow study instructions, including wearing a glucose monitor. Participants should have been diagnosed at least 3 months ago and not be on insulin or GLP-1 receptor agonists. They must not have severe kidney issues, untreated eye problems, certain liver conditions, GI disorders affecting medication absorption, coagulopathy requiring anticoagulants (except low-dose aspirin), or active infections like hepatitis or HIV.Check my eligibility
What is being tested?
The study tests the effects of ultrasound treatment on the liver to improve whole-body insulin sensitivity in diabetic patients. It involves monitoring blood sugar levels continuously and assessing how well the body uses insulin through various tests such as OGTT with carbon-13 labeled glucose and an HE Clamp procedure.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from continuous glucose monitoring devices, reactions to oral glucose tolerance test substances or procedures involved in hepatic ultrasound treatment. Side effects related to liver NMR imaging could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Type 2 Diabetes based on my blood sugar levels.
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I am willing to wear a glucose monitor for over 10 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured during he clamp.
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured during he clamp. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Glucose disposal rate
Glucose metabolic clearance rate
Insulin Sensitivity
Secondary outcome measures
Absolute glycogen level
Average daily glucose
Change from baseline in blood glucose (BG) time spent in defined glucose ranges
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4: Dual site ultrasound stimulation followed by CGM glucose recording alone.Experimental Treatment2 Interventions
Hepatoportal plexus + superior mesenteric plexus dual site ultrasound stimulation followed by CGM glucose recording alone.
Group II: Cohort 3: Ultrasound then NMR with carbon13 labeled glucose.Experimental Treatment3 Interventions
Hepatic ultrasound and subsequent NMR measurement of glycogen with carbon13 labeled glucose.
Group III: Cohort 2: Ultrasound then NMR with unlabeled glucose.Experimental Treatment3 Interventions
Hepatic ultrasound and subsequent NMR measurement of glycogen with unlabeled glucose.
Group IV: Cohort 1: Ultrasound during a hyperinsulinemic euglycemic clamp (HEC).Experimental Treatment3 Interventions
Hepatic ultrasound during a hyperinsulinemic euglycemic clamp (HEC).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound
2013
Completed Phase 1
~1950

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,315,164 Total Patients Enrolled
8 Trials studying Insulin Sensitivity
1,605 Patients Enrolled for Insulin Sensitivity
Yale UniversityLead Sponsor
1,848 Previous Clinical Trials
2,737,741 Total Patients Enrolled
2 Trials studying Insulin Sensitivity
60 Patients Enrolled for Insulin Sensitivity
Raimund Herzog, MD, MHSPrincipal InvestigatorYale University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does your research include participants aged 35 and older?

"The minimum age for eligibility in this trial is 18, with the maximum capped at 80."

Answered by AI

Does my eligibility meet the criteria for this research endeavor?

"This study requires that participants have insulin sensitivity and are aged 18 to 80 years old. A total of 77 individuals need to be recruited for this trial."

Answered by AI

Does this trial still have openings for participants?

"As detailed on clinicaltrials.gov, this study is no longer attempting to enroll new participants. Initially posted on September 1st 2023 and last updated 2 weeks later, the trial has already filled out its participant spots; however, 168 other trials are currently in need of volunteers right now."

Answered by AI

What are the major goals of this medical experiment?

"The primary goal of this clinical trial, evaluated over the course of ~HE clamp, is to assess Glucose disposal rate. Secondary outcomes include Glycogen synthesis rates (calculated from plasma 13C -glucose levels and appearance in liver glycogen), Change from baseline in blood glucose time spent within specified ranges (measured by CGMS device), and Average daily glucose (also measured via a continuous glucose monitoring system)."

Answered by AI
~51 spots leftby Sep 2027