Mechanisms of Ultrasound Neuromodulation Effects in Diabetes

Launched by YALE UNIVERSITY · Sep 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a special type of ultrasound treatment can improve insulin sensitivity in people with Type 2 diabetes. Insulin sensitivity is how well your body responds to insulin, which is important for controlling blood sugar levels. The researchers want to see if this treatment can lead to better blood sugar control during a specific test called a hyperinsulinemic euglycemic clamp (HE Clamp), which helps measure how well your body uses insulin.

To participate in the study, you need to be between 18 and 80 years old and have been diagnosed with Type 2 diabetes for at least three months. You should also be following a diet and exercise plan or taking oral medications for diabetes, but not insulin. Additionally, you will need to wear a continuous glucose monitor for ten days and come to the lab for certain tests. However, there are some health conditions that would exclude you from joining, like having a very high body weight or certain heart and liver problems. If you are interested, the study team will provide more details about what to expect and the steps involved.

Gender

ALL

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 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.