RecruitingNot applicable

Ultrasound Effects on Glycemic Control in T2DM

Effects of Multi-Site Abdominal Ultrasound Stimulation on Glycemic Control in T2DM

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "This study will test whether multi-site abdominal ultrasound stimulation can have lasting effects on elevated glucose levels in patients with diabetes."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small, early study tests whether focused pulses of ultrasound at two body sites affect blood sugar. It is for adults ages 21 to 75 with type 2 diabetes who take certain diabetes pills.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have had type 2 diabetes for at least 3 months.
  • Be 21 to 75 years old.
  • Take a steady dose of one or more allowed diabetes pills: metformin, sulfonylureas, meglitinides, or thiazolidinediones. No increase in treatment must be planned.
  • Have an HbA1c above 7% and below 10%. This blood test shows average blood sugar over time.
  • Have a body mass index (BMI) from 18 to 40. BMI compares weight with height.
  • Be generally healthy based on the study doctor's exam, health history, and blood tests.
  • If female, not be pregnant or breastfeeding, and have negative blood pregnancy tests at screening and before ultrasound treatment.
  • Be able to give written consent to join.

Who can't join

  • Have type 1 diabetes; use insulin, DPP-4 inhibitors, or GLP agonists; need stronger diabetes treatment; or have screening results showing a risk of low blood sugar or very poorly controlled diabetes. More than one severe low-blood-sugar event within 6 months also excludes you.
  • Have advanced diabetes damage to the eyes, nerves, heart, or blood vessels; certain heart problems or abnormal heart rhythms; or a heart or blood vessel procedure within 6 months. A personal or family history of excess blood clotting or dangerous blood clots also excludes you.
  • Have active cancer, kidney disease or low kidney function, liver disease or important abnormal liver tests, or certain mental health conditions that could affect safety or study results.
  • Have had weight-loss or other stomach or bowel surgery, including appendix or gallbladder removal; poor food absorption; very slow stomach emptying; or major digestive problems. Major surgery within 3 months or a recent serious injury also excludes you.
  • Have a history of seizures, have taken part in a nerve stimulation study, or have a current or past implanted nerve stimulator or another implanted electronic medical device. You also cannot join if you cannot understand instructions or cooperate, cannot tolerate adhesive tape, or have an ongoing skin reaction where the glucose sensor goes.
  • Have a recent active infection within 30 days, except a mild viral illness such as a cold; a history of or positive test for hepatitis B, hepatitis C, or HIV; or have donated or lost more than 500 mL of blood or blood products within 2 months.
  • Use prohibited medicines or other medicines that affect blood sugar or insulin. Thyroid medicine must have been at a steady dose for at least 3 months. Recent participation in another research study also excludes you: the wait is at least 30 days, or longer depending on how long the study drug stays in the body.
  • Have had an abdominal ultrasound within 1 month, have an ultrasound planned during the study, or need an outside ultrasound during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Male or female subjects with a diagnosis of type 2 diabetes ≥ 3 months. 2. Age ≥ 21 and ≤ 75 years. 3. 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 4. HbA1c \> 7.0% and \< 10% by local laboratory analysis. 5. Body Mass Index (BMI) ≥ 18 to ≤ 40.0 kg/m2. 6. Considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Principal Investigator. 7. Female subjects must be non-pregnant and non-lactating and have a negative serum pregnancy test at screening and before the ultrasound session. 8. Ability to provide written informed consent. Exclusion Criteria: 1. History or current diagnosis with T1DM or T2DM subjects on insulin, DPP-4 inhibitors, GLP agonists. 2. A subject who is already indicated for medication escalation of their current diabetic therapy. 3. 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. 4. 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. 5. Invasive cardiovascular procedure, such as coronary artery bypass graft surgery (CABG), or angioplasty/percutaneous coronary intervention (PCI) within 6 months of screening. 6. History of recurrent severe hypoglycemia (more than 1 event ≤ 6 month) 7. Subjects with clinically active malignancy 8. 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). 9. 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). 10. 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. 11. Personal or family history of hypercoagulability or thromboembolic disease, including deep vein thrombosis and/or pulmonary embolism (PE) 12. 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. 13. History of any major surgery within 3 months prior to screening. 14. 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. 15. 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. 16. 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. 17. Thyroid hormone use is not allowed unless medication is given on a stable dose for at least 3 months prior to screening. 18. Subject is unable to tolerate adhesive tape or has any unresolved adverse skin reaction in the area of the glucose sensor placement. 19. Implanted pacemaker or cardioverter/defibrillator (AICD). 20. 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. 21. 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). 22. History of any recent traumatic injury, including intracerebral hemorrhage and visceral injury. 23. Donation or loss of \> 500 mL of blood or blood product within 2 months prior to screening. 24. Mental incapacity, unwillingness or language barriers precluding adequate understanding and to follow verbal commands during the ultrasound session or cooperation. 25. 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 study. 26. Use of the agents listed in Prohibited Medications Table below (prescription or nonprescription) is prohibited until completion of all study activities. 27. Identification of risk of hypoglycemia or severely uncontrolled diabetes in screening visit metabolic assessments (CGM, OGTT, and fasting blood draws)

Study sites (1)

CT