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Ultrasound Neuromodulation for Insulin Sensitivity in Type 2 Diabetes

This study is looking at how ultrasound treatment to the liver might affect insulin sensitivity in people with Type 2 diabetes. Participants will receive ultrasound using a General Electric LOGIQ E10 system. Researchers will measure insulin sensitivity (how well your body uses insulin) using a special test called a hyperinsulinemic-euglycemic clamp (HEC), and also track glucose levels with a continuous glucose monitor (CGM). The goal is to see if ultrasound can improve how your body responds to insulin. You may be eligible if you are 18-80 years old, have Type 2 diabetes for at least 3 months, and are not currently using insulin or GLP-1 receptor agonists. The study aims to enroll 77 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 77 participants. It involves different diagnostic tests to measure insulin sensitivity and glucose metabolism.
What's involved
You will have a screening visit, two outpatient ultrasound treatment visits, and a third ultrasound session. You will then undergo either an oral glucose tolerance test (OGTT) with carbon-13 labeled glucose or a hyperinsulinemic-euglycemic clamp (HEC) test, followed by about two weeks of continuous glucose monitoring. This cycle will be repeated after a two-week break.
Compensation
Not stated in the trial record.
Follow-up
After the procedures, there will be an approximately two-week follow-up observational period with continuous glucose monitoring.

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NCT06042517

Mechanisms of Ultrasound Neuromodulation Effects in Diabetes

Recruiting
NAAges 18–80Interventional
Yale University
~77 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:UltrasoundOGTT with unlabeled glucose and liver NMROGTT with carbon-13 labeled glucose and liver NMRCGM glucose readingHEC - Hyperinsulinemic-Euglycemic-Clamp

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Insulin Sensitivity
Measured over Measured during HE clamp.
+2 more outcomes measured

Conditions

Insulin Sensitivity

Explore related trials

Type 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Raimund Herzog, MD, MHS · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Raimund Herzog, MD MHS
[email protected]
+1 (203) 737-4773
Email the study team

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Eligibility criteria

Inclusion

Type 2 diabetic (T2D) subjects must be aged 18-80 and must be able to provide written informed consent
All subjects must have had T2D for at least 3 months prior to study enrollment. All subjects must be either on diet and exercise or oral antidiabetic agents alone, not on insulin or any form of insulin or GLP-1 receptor agonists.
Subjects must demonstrate:
A fasting plasma glucose (FPG) level of 126 mg/dL (7.0 mmol/L) or higher, or
A 2-hour plasma glucose level of 200 mg/dL (11.1 mmol/L) or higher during a 75-g oral glucose tolerance test (OGTT), or
A random plasma glucose of 200 mg/dL (11.1 mmol/L) or higher in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis or
A hemoglobin A1c (HbA1c) level of 6.5% or higher. 2. Be willing to carry a continuous glucose monitor for at least 10 days. 3. Be willing to follow all required instructions by study personnel and appear for the required laboratory assessments, including euglycemic clamps and OGTT.

Exclusion

BMI \>40kg/m2.
Untreated proliferative retinopathy
Creatinine clearance \< 60 ml/min/1.73 m2.
Serum creatinine ≥1.5 mg/dL
Positive pregnancy test, or presently breast-feeding, or failure to follow effective contraceptive measures
Active infection including hepatitis C, hepatitis B, HIV,
Any history of Active alcohol abuse
History of non-adherence to prescribed regimens
Baseline Hgb \< 10.5 g/dL in females, or \< 13 g/dL in males
History of coagulopathy or medical condition requiring long-term anticoagulant therapy (low-dose aspirin treatment is allowed)
Co-existing cardiac disease with active medication titration. Patients on stable meds without active cardiac complications permitted.
Liver function tests outside of 3xUL of normal range
GI disorders potentially interfering with the ability to absorb oral medications and h/o upper GI surgery that might have changed anatomy in the target areas.
Any medical condition or medication that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes.

What this trial measures

  • Insulin SensitivityMeasured during HE clamp.

    Insulin Sensitivity calculated as Glucose disposal rate / insulin ratio during steady state (M/I) to evaluate the effect of hepatic ultrasound treatment on changes from baseline in whole-body insulin sensitivity during a hyperinsulinemic, euglycemic clamp (HE Clamp)

  • Glucose disposal rateMeasured during HE clamp.

    Glucose disposal rate during steady state (M) to evaluate the effect of hepatic ultrasound treatment on changes from baseline in whole-body insulin sensitivity during a hyperinsulinemic, euglycemic clamp (HE Clamp)

  • Glucose metabolic clearance rateMeasured during HE clamp.

    Glucose metabolic clearance rate during steady state (MCR) to evaluate the effect of hepatic ultrasound treatment on changes from baseline in whole-body insulin sensitivity during a hyperinsulinemic, euglycemic clamp (HE Clamp)