Mechanisms of Ultrasound Neuromodulation Effects in Diabetes

Insulin Sensitivity Clinical Trial

Official title: Mechanisms of Ultrasound Neuromodulation Effects in Diabetes

Status Recruiting

Clinical Trial 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).

Clinical Trial 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 two-week washout period will be followed by another cycle of the same procedures of either OGTT/NMR or HEC study, respectively. ;

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity

• NCT number: NCT06042517
• Study type: Interventional
• Source: Yale University
• Contact: Raimund Herzog, MD MHS
• Phone: +1 (203) 737-4773
• Email: raimund.herzog@yale.edu
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2023
• Completion date: September 30, 2027