Effects of ultrasound treatment on insulin sensitivity in diabetes

Mechanisms of Ultrasound Neuromodulation Effects in Diabetes

This study is testing whether ultrasound treatment can help improve insulin sensitivity in people with Type 2 diabetes.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 77 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Yale University (other)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT06042517 on ClinicalTrials.gov

What this trial studies

This study evaluates how hepatic ultrasound treatment influences whole-body insulin sensitivity in individuals with Type 2 diabetes. Participants will undergo a series of outpatient ultrasound sessions followed by either an Oral Glucose Tolerance Test (OGTT) or a Hyperinsulinemic-Euglycemic Clamp (HEC) test. The study includes a two-week follow-up observational period with continuous glucose monitoring to assess changes in insulin sensitivity. The aim is to gather data on the effectiveness of ultrasound as a potential treatment for improving insulin sensitivity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with a diagnosis of Type 2 diabetes for at least three months, who are not on insulin or GLP-1 receptor agonists.

Not a fit: Patients who are not diagnosed with Type 2 diabetes or those currently using insulin or GLP-1 receptor agonists may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a non-invasive treatment option to improve insulin sensitivity in patients with Type 2 diabetes.

How similar studies have performed: While the use of ultrasound for neuromodulation is an emerging field, similar studies have shown promise in other areas, making this approach potentially novel yet grounded in preliminary success.

Eligibility criteria

Inclusion Criteria:

* 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:

  1. A past medical history of abnormal glucose control and carry a diagnosis of T2D according to current ADA criteria:

     * 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 Criteria:

* 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.

Where this trial is running

New Haven, Connecticut

• Yale School of Medicine — New Haven, Connecticut, United States (RECRUITING)

Study contacts

• Principal investigator: Raimund Herzog, MD, MHS — Yale University
• Study coordinator: Raimund Herzog, MD MHS

Conditions: Insulin Sensitivity