NCT06042517

Mechanisms of Ultrasound Neuromodulation Effects in Diabetes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 77 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Insulin Sensitivity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-30
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2023-09-18
• Last updated: 2025-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study