Mechanisms of Ultrasound Neuromodulation Effects in Diabetes
Recruiting
N/AInterventional Study
Insulin Sensitivity
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
77 (estimated)
Sponsor
Yale University · Other
Who this trial is looking for
This trial is looking for adults with type 2 diabetes to evaluate the effects of ultrasound treatment on insulin sensitivity. Participants will need to follow some instructions and complete laboratory assessments during the study.
Are You a Good Fit for This Trial?
Rules you outSevere cardiac diseaseLiver dysfunctionSignificant GI disorders
You may be able to join if
I am between 18 and 80 years old.
I have been diagnosed with type 2 diabetes.
I have had type 2 diabetes for at least 3 months.
I am not on insulin or GLP-1 receptor agonists.
I have a history of abnormal glucose control.
I agree to use a continuous glucose monitor for 10 days.
I can follow all required instructions from study staff.
I can attend all required assessments.
You may not be able to join if
My BMI is over 40 kg/m2.
I have untreated proliferative retinopathy.
My kidney function is low (creatinine clearance less than 60 ml/min).
My creatinine level is 1.5 mg/dL or higher.
I am pregnant, breastfeeding, or not using effective birth control.
I have an active infection like hepatitis C, hepatitis B, or HIV.
I have a history of active alcohol abuse.
I have low hemoglobin levels (under 10.5 g/dL for females or under 13 g/dL for males).
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study aims to evaluate the effect of hepatic ultrasound treatment on changes from baseline in whole-body insulin sensitivity during a hyperinsulinemic, euglycemic clamp (HE Clamp).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Type 2 diabetic (T2D) subjects must be aged 18-80 and must be able to provide written informed consent
* All subjects must have had T2D for at least 3 months prior to study enrollment. All subjects must be either on diet and exercise or oral antidiabetic agents alone, not on i…
Inclusion Criteria:
* Type 2 diabetic (T2D) subjects must be aged 18-80 and must be able to provide written informed consent
* All subjects must have had T2D for at least 3 months prior to study enrollment. All subjects must be either on diet and exercise or oral antidiabetic agents alone, not on insulin or any form of insulin or GLP-1 receptor agonists.
* Subjects must demonstrate:
1. A past medical history of abnormal glucose control and carry a diagnosis of T2D according to current ADA criteria:
* A fasting plasma glucose (FPG) level of 126 mg/dL (7.0 mmol/L) or higher, or
* A 2-hour plasma glucose level of 200 mg/dL (11.1 mmol/L) or higher during a 75-g oral glucose tolerance test (OGTT), or
* A random plasma glucose of 200 mg/dL (11.1 mmol/L) or higher in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis or
* A hemoglobin A1c (HbA1c) level of 6.5% or higher.
2. Be willing to carry a continuous glucose monitor for at least 10 days.
3. Be willing to follow all required instructions by study personnel and appear for the required laboratory assessments, including euglycemic clamps and OGTT.
Exclusion Criteria:
* BMI \>40kg/m2.
* Untreated proliferative retinopathy
* Creatinine clearance \< 60 ml/min/1.73 m2.
* Serum creatinine ≥1.5 mg/dL
* Positive pregnancy test, or presently breast-feeding, or failure to follow effective contraceptive measures
* Active infection including hepatitis C, hepatitis B, HIV,
* Any history of Active alcohol abuse
* History of non-adherence to prescribed regimens
* Baseline Hgb \< 10.5 g/dL in females, or \< 13 g/dL in males
* History of coagulopathy or medical condition requiring long-term anticoagulant therapy (low-dose aspirin treatment is allowed)
* Co-existing cardiac disease with active medication titration. Patients on stable meds without active cardiac complications permitted.
* Liver function tests outside of 3xUL of normal range
* GI disorders potentially interfering with the ability to absorb oral medications and h/o upper GI surgery that might have changed anatomy in the target areas.
* Any medical condition or medication that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes.
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