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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

Must not have

Active infection including hepatitis C, hepatitis B, HIV

Positive pregnancy test, presently breast-feeding, or failure to follow effective contraceptive measures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during glucose tolerance testing (for 180 minutes).

Awards & highlights

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active infections like hepatitis C, hepatitis B, or HIV.

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I am not pregnant, breastfeeding, and I use effective birth control.

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I have a blood clotting disorder or need long-term blood thinners (except low-dose aspirin).

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I have stomach or intestine problems that could affect how I absorb pills.

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I have an untreated eye condition where new blood vessels grow abnormally.

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My hemoglobin level is low according to my gender.

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

~4090

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

2,381 Previous Clinical Trials

4,315,025 Total Patients Enrolled

8 Trials studying Insulin Sensitivity

1,605 Patients Enrolled for Insulin Sensitivity

Yale UniversityLead Sponsor

1,874 Previous Clinical Trials

2,953,479 Total Patients Enrolled

2 Trials studying Insulin Sensitivity

60 Patients Enrolled for Insulin Sensitivity

Raimund Herzog, MD, MHSPrincipal InvestigatorYale University

~51 spots leftby Sep 2027

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