Mechanisms of Ultrasound Neuromodulation Effects in Diabetes

Yale University

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).

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. On day three subjects first undergo a third ultrasound session and then will either undergo Oral Glucose Tolerance Test (OGTT) with carbon13 (13C-glucose) tracer administration and subsequent NMR spectroscopy OR if enrolled into the HEC study arm will undergo euglycemic clamp testing. Following these procedures there will be an approximately two-week follow-up observational Period (with CGM). A tw…

Eligibility

Age range: 18–80 years
Sex: All
Healthy volunteers: No

Detailed 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 *…

Interventions

Device
Ultrasound
The General Electric LOGIQ E10 ultrasound pulsed doppler imaging system and C1-6-D XDclear abdominal curvilinear probe will be used to administer ultrasound.
Diagnostic Test
OGTT with unlabeled glucose and liver NMR
Subjects will undergo an OGTT with unlabeled glucose to measure liver glycogen concentration by NMR spectroscopy.
Diagnostic Test
OGTT with carbon-13 labeled glucose and liver NMR
Subjects will undergo an OGTT with carbon-13 labeled glucose to measure liver glycogen synthesis rate by NMR spectroscopy.
Diagnostic Test
CGM glucose reading
A continuous glucose monitor (CGM) will be collecting glucose level changes over a 10-14day time period after the ultrasound.
Diagnostic Test
HEC - Hyperinsulinemic-Euglycemic-Clamp
A constant i.v. insulin and variable glucose infusion will be used to determine insulin sensitivity of study participants.

Location

Yale School of Medicine
New Haven, Connecticut