Mechanisms of Ultrasound Neuromodulation Effects in Diabetes

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06042517
Status
Recruiting
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Conditions

  • Insulin Sensitivity

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Sep 30, 2023
Status verified
May 2025
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
77 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Cohort 1: Ultrasound during a hyperinsulinemic euglycemic clamp (HEC).
    Hepatic ultrasound during a hyperinsulinemic euglycemic clamp (HEC).
  • Experimental: Cohort 2: Ultrasound then NMR with unlabeled glucose.
    Hepatic ultrasound and subsequent NMR measurement of glycogen with unlabeled glucose.
  • Experimental: Cohort 3: Ultrasound then NMR with carbon13 labeled glucose.
    Hepatic ultrasound and subsequent NMR measurement of glycogen with carbon13 labeled glucose.
  • Experimental: Cohort 4: Dual site ultrasound stimulation followed by CGM glucose recording alone.
    Hepatoportal plexus + superior mesenteric plexus dual site ultrasound stimulation followed by CGM glucose recording alone.

Primary Outcome Measure

Insulin Sensitivity [ Time Frame: Measured during HE clamp. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale School of MedicineNew HavenConnecticut06520-

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By research site
Yale School of Medicine· New Haven, CT

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