Sound waves to the liver: a new weapon against diabetes?
NCT ID NCT06042517
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This trial asks whether focused ultrasound pulses aimed at the liver can improve how the body responds to insulin in people with type 2 diabetes. Participants will receive the ultrasound treatment and then undergo tests, including a glucose clamp and liver imaging, to measure changes in insulin sensitivity and liver glycogen. The study includes adults with type 2 diabetes who manage their condition with diet or oral medications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ultrasound pulses directed at the liver
- What this could lead to
- If it works, this could point toward a non-invasive, drug-free way to improve insulin sensitivity and help manage type 2 diabetes.
- What could go wrong
- This is an early, small study focused on understanding mechanisms, not yet a proven treatment. Effects may be modest or not translate into lasting clinical benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 77 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Yale School of Medicine
RECRUITINGNew Haven, Connecticut, 06520, United States
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