Ultrasound for Type 2 Diabetes
(U/S_in_T2DM Trial)
Trial Summary
Do I need to stop my current medications for the trial?
The trial requires participants to be on a stable treatment regimen of certain oral anti-diabetic drugs like Metformin, Sulfonylureas, Meglitinides, or Thiazolidinediones. Other medications that interfere with glucose or insulin metabolism are prohibited, so you may need to stop those.
What data supports the effectiveness of the treatment Ultrasound Delivery for Type 2 Diabetes?
There is no direct evidence from the provided research articles supporting the effectiveness of ultrasound delivery for treating Type 2 Diabetes. However, ultrasound is used in managing gestational diabetes by guiding treatment based on fetal growth, which suggests it can play a role in diabetes management.12345
Is ultrasound treatment generally safe for humans?
How does ultrasound treatment for Type 2 Diabetes differ from other treatments?
Ultrasound treatment for Type 2 Diabetes is unique because it uses sound waves to potentially improve clinical assessments and management of diabetes-related conditions, unlike traditional treatments that often involve medication or lifestyle changes. This approach is novel as it may help in detecting cardiovascular risks and other complications more sensitively than standard clinical examinations.1112131415
What is the purpose of this trial?
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.
Research Team
Raimund Herzog, MD
Principal Investigator
Yale University
Eligibility Criteria
Adults aged 21-75 with Type 2 Diabetes, BMI of 18 to ≤40 kg/m2, stable on certain oral diabetes meds (like Metformin), and not on insulin or other excluded drugs. They should have an HbA1c level between >7% and <10%, be generally healthy, and women must not be pregnant. Excluded are those with heart disease, severe hypoglycemia history, recent major surgery or infections like COVID-19.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dual site focused pulsed ultrasound treatment on the liver and intestinal target sites
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ultrasound Delivery
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
GE Healthcare
Industry Sponsor
Fotis Vlachos
GE Healthcare
Chief Marketing Officer since 2024
PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania
Peter J. Arduini
GE Healthcare
Chief Executive Officer since 2022
MBA from Northwestern University, BSc in Marketing from Susquehanna University