Actively Recruiting

Phase Not Applicable
Age: 21Years - 75Years
All Genders
NCT05354947

Ultrasound Effects on Glycemic Control in T2DM

Led by Yale University · Updated on 2026-01-27

30

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

G

GE Healthcare

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Ultrasound Effects on Glycemic Control in T2DM

Who Can Participate

Age: 21Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female subjects with type 2 diabetes diagnosed at least 3 months ago
  • Age between 21 and 75 years
  • On stable oral anti-diabetic drugs including metformin, sulfonylureas, meglitinides, or thiazolidinediones without planned medication changes
  • HbA1c greater than 7.0% and less than 10% by local lab analysis
  • Body mass index (BMI) between 18 and 40 kg/m2
  • Generally healthy as determined by medical history, physical exam, and lab tests
  • Female participants must be non-pregnant, non-lactating, and have a negative pregnancy test at screening and before ultrasound
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Diagnosis of type 1 diabetes or use of insulin, DPP-4 inhibitors, or GLP agonists
  • Indicated for medication escalation of diabetes therapy
  • Advanced diabetes complications such as retinopathy, neuropathy, or cardiovascular disease
  • History or current cardiac dysrhythmias, symptomatic heart failure (NYHA III or IV), myocardial infarction, or unstable angina
  • Cardiovascular surgery or procedures within 6 months prior to screening
  • Recurrent severe hypoglycemia events (more than 1 in 6 months)
  • Active malignancy
  • Renal disease or kidney function impairment (GFR < 60 mL/min/1.73m2)
  • Active liver disease or abnormal liver function tests suggestive of hepatic impairment
  • Psychiatric disorders that could affect study results or safety
  • History or family history of blood clotting disorders
  • History of bariatric or major gastrointestinal surgery or severe GI disorders
  • Major surgery within 3 months before screening
  • Use of implanted nerve or cardiac devices
  • Participation in another investigational study within 30 days or 5 half-lives of last dose
  • Use of drugs interfering with glucose or insulin metabolism (except stable thyroid hormone use)
  • Inability to tolerate adhesive tape or skin reaction at glucose sensor site
  • Active infections, including recent COVID-19 infection
  • Positive tests for hepatitis B, hepatitis C, or HIV
  • Recent traumatic injury
  • Blood donation or loss exceeding 500 mL within 2 months
  • Mental incapacity, language barriers, or inability to cooperate
  • Recent abdominal ultrasound within 1 month or need for outside ultrasound during study
  • Use of prohibited medications as listed
  • Risk of hypoglycemia or severely uncontrolled diabetes detected at screening

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Yale-New Haven Hospital

New Haven, Connecticut, United States, 06510

Actively Recruiting

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Research Team

A

Alice Hahn

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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