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Mechanisms of Ultrasound Neuromodulation Effects in Diabetes

NCT06042517 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2025-05-08

No results posted yet for this study

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).

Conditions

  • Insulin Sensitivity

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.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Raimund Herzog, MD, MHS · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06042517 on ClinicalTrials.gov