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Recruiting NCT06042517

Mechanisms of Ultrasound Neuromodulation Effects in Diabetes

Trial Parameters

Condition Insulin Sensitivity
Sponsor Yale University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 77
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2023-09-30
Completion 2027-09-30
Interventions
UltrasoundOGTT with unlabeled glucose and liver NMROGTT with carbon-13 labeled glucose and liver NMR

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).

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 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

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