Type 2 DiabetesU/S_in_T2DMNCT05354947
Ultrasound Effects on Glycemic Control in T2DM
A study testing Ultrasound Delivery in people with Type 2 Diabetes, run by Yale University at 1 site in United States.
Trial summary
This is an open label, exploratory pilot study that will assess the effects of dual site focused pulsed ultrasound treatment on glycemic parameters in subjects with T2DM. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Ultrasound Delivery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects with a diagnosis of type 2 diabetes ≥ 3 months.
- Age ≥ 21 and ≤ 75 years.
- Currently on a stable treatment regimen of oral anti-diabetic drugs and not currently prescribed for medication escalation. Oral anti-diabetic drugs are limited to one or more of the following:
- Metformin
- Sulfonylureas
- Meglitinides
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- Thiazolidinediones
- HbA1c > 7.0% and < 10% by local laboratory analysis.
- Body Mass Index (BMI) ≥ 18 to ≤ 40.0 kg/m2.
- Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Principal Investigator.
- Female subjects must be non-pregnant and non-lactating and have a negative serum pregnancy test at screening and before the ultrasound session.
- Ability to provide written informed consent.
Who cannot join
- History or current diagnosis with T1DM or T2DM subjects on insulin, DPP-4 inhibitors, GLP agonists.
- A subject who is already indicated for medication escalation of their current diabetic therapy.
- A subject who has manifestations of advanced complications from poorly controlled or longstanding diabetes such as diabetic retinopathy, diabetic neuropathy and cardiovascular complications including, but not limited to coronary artery disease, peripheral vascular disease, or cerebrovascular disease such as transient ischemic attack [TIA], cerebral infarct, or cerebral hemorrhage.
- History or current diagnosis of cardiac dysrhythmias or heart disease, defined as symptomatic heart failure (New York Heart Association class III or IV), myocardial infarction, unstable angina requiring medication.
- Invasive cardiovascular procedure, such as coronary artery bypass graft surgery (CABG), or angioplasty/percutaneous coronary intervention (PCI) within 6 months of screening.
- History of recurrent severe hypoglycemia (more than 1 event ≤ 6 month)
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- Subjects with clinically active malignancy
- History of renal disease or abnormal kidney function tests at Screening (glomerular filtration rate [GFR] < 60 mL/min/1.73m2 as estimated using the MDRD equation).
- History or active hepatic disease or clinically significant abnormal hepatic function tests at Screening suggestive of hepatic impairment (e.g., ALT and/or AST >2 x ULN, GGT >2 x ULN, total bilirubin > 1 x ULN).
- Subjects with a history or presence of any psychiatric disorder that, in the opinion of the Principal Investigator, might confound the results of the trial or pose additional risk in administering the investigational product to the subject.
- Personal or family history of hypercoagulability or thromboembolic disease, including deep vein thrombosis and/or pulmonary embolism (PE)
- History of surgical treatment for obesity (bariatric surgery, gastric banding, etc.) or any other gastrointestinal surgery (including appendectomy, cholecystectomy), any malabsorption disorder, severe gastroparesis, any GI procedure for weight loss (including LAP-BAND®), as well as clinically significant gastrointestinal disorders (e.g. peptic ulcers, severe GERD) at Screening.
- History of any major surgery within 3 months prior to screening.
- Any nerve stimulation study or implanted stimulator, including previously or currently implanted vagus nerve stimulator, previously or currently implanted spinal cord stimulator, other implanted electronic medical device, such as implanted pacemaker or cardioverter/ defibrillator (AICD) or history of seizures.
- Participation in an investigational study within 30 days prior to dosing or 5 half-lives within the last dose of the investigational product given during the investigational study, whichever is longer.
- Current use of any drugs (other than current treatment for diabetes mellitus) that are known to interfere with glucose or insulin metabolism as stated below in table prohibited medication.
- Thyroid hormone use is not allowed unless medication is given on a stable dose for at least 3 months prior to screening.
- Subject is unable to tolerate adhesive tape or has any unresolved adverse skin reaction in the area of the glucose sensor placement.
- Implanted pacemaker or cardioverter/defibrillator (AICD).
- History of any active infection, incl. COVID19 (as ruled out by negative PCR test), except mild viral disease, such as common cold, within 30 days prior to screening.
- Known history or positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus type 1 (HIV-1) or type 2 (HIV-2).
- History of any recent traumatic injury, including intracerebral hemorrhage and visceral injury.
- Donation or loss of > 500 mL of blood or blood product within 2 months prior to screening.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding and to follow verbal commands during the ultrasound session or cooperation.
- An abdominal ultrasound scan or exam within 1 month prior to screening and/or any pre-planned ultrasound examinations during the study, or the need to participate in any unplanned outside ultrasound procedures during study.
- Use of the agents listed in Prohibited Medications Table below (prescription or nonprescription) is prohibited until completion of all study activities.
- Identification of risk of hypoglycemia or severely uncontrolled diabetes in screening visit metabolic assessments (CGM, OGTT, and fasting blood draws)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale-New Haven Hospital
New Haven, Connecticut, 06510
Alice Hahn, 475-321-0504, diabetes.research@yale.edu
Raimund Herzog, MD
About this study
Official title: Effects of Multi-Site Abdominal Ultrasound Stimulation on Glycemic Control in T2DM
This is an open label, exploratory pilot study that will assess the effects of dual site focused pulsed ultrasound treatment on glycemic parameters in subjects with T2DM.
Read the detailed description
This study will test whether multi-site abdominal ultrasound stimulation can have lasting effects on elevated glucose levels in patients with diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- Ultrasound Delivery
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound DeliveryDevice
A General Electric LOGIQ E10 ultrasound machine with a C1-6-XD clear probe, will be used to selectively deliver pulsed ultrasound to both, the portal region of the liver and the superior mesenteric plexus.
| Study group | Role | What they receive |
|---|---|---|
| 30 minute, dual site stimulation | Experimental | Ultrasound Deliveryfor 30 minutes total: 15 minutes on the liver target site and 15 minutes on the intestinal target site. Receives: Device: Ultrasound Delivery |
| 60 minute, dual site stimulation | Experimental | Ultrasound Delivery for 60 minutes total: 30 minutes on the liver target site and 30 minutes on the intestinal target site. Receives: Device: Ultrasound Delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Hepatic Adverse Events - Elevation of liver transaminases AST / ALT.
Number of study participants who develop an elevation of liver transaminases compared to baseline parameters, including AST and ALT.
Grade 1 delta ALT and / or AST <3 x ULN; Grade 2 delta ALT and / or AST >3 - 5 x ULN; Grade 3 delta ALT and / or AST >5 - 20 x ULN; Grade 4 delta ALT and / or AST >20 x ULN.
Measured: 2 weeks
Secondary outcomes (1)
Number of Metabolism and nutrition disorders - Hypoglycemia
Number of study participants who develop Hypoglycemia (- A disorder characterized by laboratory test results that indicate a low concentration of glucose in the blood) after undergoing the study procedure.
Grade 1 <LLN - 55 mg/dL; <LLN - 3.0 mmol/L Grade 2 <55 - 40 mg/dL; <3.0 - 2.2 mmol/L Grade 3 <40 - 30 mg/dL; <2.2 - 1.7 mmol/L Grade 4 <30 mg/dL; <1.7 mmol/L; Grade 5 life-threatening consequences; seizures Death
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Nov 2022
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
- Investigators
- Raimund Herzog, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05354947
- Sponsor's protocol ID
- 2000032493
- Acronym
- U/S_in_T2DM
- Status last verified
- Jan 2026
- First submitted
- 5 Apr 2022
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multi-Site Abdominal Ultrasound Stimulation on Glycemic Control in T2DM
- ClinicalTrials.gov ID
- NCT05354947
- Acronym / sponsor ID
- U/S_in_T2DM / 2000032493
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, exploratory pilot study that will assess the effects of dual site focused pulsed ultrasound treatment on glycemic parameters in subjects with T2DM.
Detailed description
This study will test whether multi-site abdominal ultrasound stimulation can have lasting effects on elevated glucose levels in patients with diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 minute, dual site stimulation | Experimental | Device: Ultrasound DeliveryUltrasound Deliveryfor 30 minutes total: 15 minutes on the liver target site and 15 minutes on the intestinal target site. |
| 60 minute, dual site stimulation | Experimental | Device: Ultrasound DeliveryUltrasound Delivery for 60 minutes total: 30 minutes on the liver target site and 30 minutes on the intestinal target site. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female subjects with a diagnosis of type 2 diabetes ≥ 3 months.
- Age ≥ 21 and ≤ 75 years.
- Currently on a stable treatment regimen of oral anti-diabetic drugs and not currently prescribed for medication escalation. Oral anti-diabetic drugs are limited to one or more of the following:
- HbA1c > 7.0% and < 10% by local laboratory analysis.
- Body Mass Index (BMI) ≥ 18 to ≤ 40.0 kg/m2.
Key exclusion criteria (27 listed)
- History or current diagnosis with T1DM or T2DM subjects on insulin, DPP-4 inhibitors, GLP agonists.
- A subject who is already indicated for medication escalation of their current diabetic therapy.
- A subject who has manifestations of advanced complications from poorly controlled or longstanding diabetes such as diabetic retinopathy, diabetic neuropathy and cardiovascular complications including, but not limited to coronary artery disease, peripheral vascular disease, or cerebrovascular disease such as transient ischemic attack [TIA], cerebral infarct, or cerebral hemorrhage.
- History or current diagnosis of cardiac dysrhythmias or heart disease, defined as symptomatic heart failure (New York Heart Association class III or IV), myocardial infarction, unstable angina requiring medication.
- Invasive cardiovascular procedure, such as coronary artery bypass graft surgery (CABG), or angioplasty/percutaneous coronary intervention (PCI) within 6 months of screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound DeliveryA General Electric LOGIQ E10 ultrasound machine with a C1-6-XD clear probe, will be used to selectively deliver pulsed ultrasound to both, the portal region of the liver and the superior mesenteric plexus. | Device | 30 minute, dual site stimulation, 60 minute, dual site stimulation |
Primary outcome
Number of Hepatic Adverse Events - Elevation of liver transaminases AST / ALT.
Time frame: 2 weeks
Number of study participants who develop an elevation of liver transaminases compared to baseline parameters, including AST and ALT. Grade 1 delta ALT and / or AST <3 x ULN; Grade 2 delta ALT and / or AST >3 - 5 x ULN; Grade 3 delta ALT and / or AST >5 - 20 x ULN; Grade 4 delta ALT and / or AST >20 x ULN.
1 secondary outcome
Number of Metabolism and nutrition disorders - Hypoglycemia
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raimund Herzog, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Delivery in people with Type 2 Diabetes, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alice Hahn (475-321-0504, alice.hahn@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Hepatic Adverse Events - Elevation of liver transaminases AST / ALT. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.