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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured during he clamp.

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,314,515 Total Patients Enrolled

8 Trials studying Insulin Sensitivity

1,605 Patients Enrolled for Insulin Sensitivity

Yale UniversityLead Sponsor

1,852 Previous Clinical Trials

2,738,364 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

Recent research and studies

clinicaltrials.govStudy

Mechanisms of Ultrasound Neuromodulation Effects in Diabetes

2023. "Mechanisms of Ultrasound Neuromodulation Effects in Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06042517.