Status:
RECRUITING
Mechanisms of Ultrasound Neuromodulation Effects in Diabetes
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Insulin Sensitivity
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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).
Detailed Description
Drop-outs will be replaced; data will be used as much as can be. Subjects will undergo a Screening visit to assess eligibility and will then be scheduled to undergo 2 outpatient US treatment visits. ...
Eligibility Criteria
Inclusion
- 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:
- 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.
- Be willing to carry a continuous glucose monitor for at least 10 days.
- Be willing to follow all required instructions by study personnel and appear for the required laboratory assessments, including euglycemic clamps and OGTT.
Exclusion
- 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.
Key Trial Info
Start Date :
September 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT06042517
Start Date
September 30 2023
End Date
September 30 2027
Last Update
May 8 2025
Active Locations (1)
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1
Yale School of Medicine
New Haven, Connecticut, United States, 06520