Ultrasound Effects on Glycemic Control in T2DM

NCT05354947 | Recruiting FDA Device

• 1 other identifier: 2000032493
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Secondary Outcomes (1)

• Number of Metabolism and nutrition disorders - Hypoglycemia

  2 weeks

Study Arms (2)

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.

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.

Device: Ultrasound Delivery

Interventions

Ultrasound Delivery DEVICE

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.

30 minute, dual site stimulation; 60 minute, dual site stimulation

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Yale University: lead
• GE Healthcare: collaborator

Study Sites (1)

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Raimund Herzog, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice Hahn

CONTACT

475-321-0504; alice.hahn@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: May 2, 2022
• Study Start: November 1, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)