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New treatment option for Type 2 Diabetes
Official title Ultrasound Effects on Glycemic Control in T2DM
ClinicalTrials.gov ID: NCT05354947
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 75
You may be able to join if
- Male or female people 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...
- Metformin
- Sulfonylureas
You likely can't join if
- History or current diagnosis with T1DM or T2DM people 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...
- History or current diagnosis of cardiac dysrhythmias or heart disease, defined as symptomatic heart failure (New York Heart Association class III or...
- Invasive cardiovascular procedure, such as coronary artery bypass graft surgery (CABG), or angioplasty/percutaneous coronary intervention (PCI)...
- History of recurrent severe hypoglycemia (more than 1 event ≤ 6 month)
See the full eligibility criteria
Who can join
- Male or female people 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 people 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.
What rules you out
- History or current diagnosis with T1DM or T2DM people 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...
- 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)
- people 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).
- people 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...
- 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...
- 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...
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.