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Ultrasound Therapy

30 minute, dual site stimulation for Type 2 Diabetes (U/S_in_T2DM Trial)

N/A
Recruiting
Led By Raimund Herzog, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently on a stable treatment regimen of oral anti-diabetic drugs limited to Metformin, Sulfonylureas, Meglitinides, Thiazolidinediones
Female subjects must be non-pregnant and non-lactating and have a negative serum pregnancy test at screening and before the ultrasound session
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights

U/S_in_T2DM Trial Summary

This trialwill explore if ultrasound can help manage diabetes symptoms in people with type 2 diabetes.

Who is the study for?
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.Check my eligibility
What is being tested?
The trial is testing the impact of focused pulsed ultrasound treatment at two body sites on blood sugar control in people with Type 2 Diabetes Mellitus (T2DM). It's an open label study where all participants know they're receiving the ultrasound treatment.See study design
What are the potential side effects?
Potential side effects aren't specified but may include discomfort at the site of ultrasound application or skin irritation from adhesive tape used for sensor placement. Since it's a pilot study assessing efficacy primarily, detailed side effect profiles will likely emerge from this initial research.

U/S_in_T2DM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am taking diabetes medication like Metformin or similar.
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I am not pregnant or breastfeeding and have a negative pregnancy test.
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I am between 21 and 75 years old.

U/S_in_T2DM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Hepatic Adverse Events - Elevation of liver transaminases AST / ALT.
Secondary outcome measures
Number of Metabolism and nutrition disorders - Hypoglycemia

U/S_in_T2DM Trial Design

2Treatment groups
Experimental Treatment
Group I: 60 minute, dual site stimulationExperimental Treatment1 Intervention
Ultrasound Delivery for 60 minutes total: 30 minutes on the liver target site and 30 minutes on the intestinal target site.
Group II: 30 minute, dual site stimulationExperimental Treatment1 Intervention
Ultrasound Deliveryfor 30 minutes total: 15 minutes on the liver target site and 15 minutes on the intestinal target site.

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,841 Previous Clinical Trials
2,734,497 Total Patients Enrolled
Raimund Herzog, MDPrincipal InvestigatorYale University
5 Previous Clinical Trials
148 Total Patients Enrolled

Media Library

Ultrasound Delivery (Ultrasound Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05354947 — N/A
Type 2 Diabetes Research Study Groups: 30 minute, dual site stimulation, 60 minute, dual site stimulation
Type 2 Diabetes Clinical Trial 2023: Ultrasound Delivery Highlights & Side Effects. Trial Name: NCT05354947 — N/A
Ultrasound Delivery (Ultrasound Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05354947 — N/A
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05354947 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been recruited for this experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, recruitment for this medical trial is still underway since its original posting date of November 1st 2022 and subsequent update dated November 10th 2022. This study requires 30 participants from one site in particular."

Answered by AI

What requirements must be met in order to become part of this experiment?

"This clinical trial requires candidates to be between 21 and 75 years of age, as well as have type 2 diabetes mellitus. Altogether, 30 participants are needed for the study."

Answered by AI

Is this clinical experiment open to individuals below the age of seventy?

"As outlined in the trial's eligibility specifications, patients must be between 21 and 75 years of age to partake."

Answered by AI

Is this clinical experiment currently enlisting participants?

"According to the data featured on clinicaltrials.gov, this medical trial is actively seeking volunteers for enrollment. The study was initially presented on November 1st 2022 and has been recently modified as of November 10th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
What site did they apply to?
Yale-New Haven Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I want to learn more and get help with my diabetes and help others by doing trials.
PatientReceived no prior treatments
~10 spots leftby Dec 2024