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CompletedNCT04622683Updated Dec 16, 2024

Effects of Hepatic Ultrasound on Metabolic Homeostasis

An interventional study of Ultrasound in Healthy and Insulin Resistance, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-16.

Sponsored by Yale University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The purpose of this study is to define the effect of ultrasound exposure of the liver in the region of the porta hepatis on glucose homeostasis and insulin resistance in healthy subjects.

02

Conditions studied

  • Healthy
  • Insulin Resistance

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03

In context

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.

This study's enrollment of 37 is close to the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 18 - 60 years of age
  • Aim 1: Healthy lean men and women, BMI\<24 kg/m2, with normal fasting glucose (blood glucose between 60 and 100mg/dl and normal glucose tolerance on OGTT (blood glucose \<140 mg/dl at 2 hours post glucose challenge) at the screening visit.
  • Aim 2: Overweight and obese men and women, BMI 25 - 35 kg/m2

Exclusion criteria

Exclusion Criteria:

  • Type 1 and type 2 diabetes
  • Surgery in the past 90 days
  • Previous surgery of the spleen or splenectomy, esophagus, lungs, stomach, duodenum, or liver
  • Recent traumatic injury, including intra-cerebral hemorrhage and visceral injury
  • End stage renal disease and/or uremia
  • Active malignancy
  • Previous leukemia and/or lymphoma
  • Human immunodeficiency virus infection or AIDS
  • Rheumatoid arthritis or other immune-mediated diseases (e.g. inflammatory bowel disease)
  • Arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, bradycardia, ventricular arrhythmias, and A-V block
  • Implanted pacemaker or cardioverter/defibrillator (AICD)
  • History of stable or unstable angina, myocardial infarction, angioplasty or coronary arterial by-pass grafting surgery
  • History of stroke or TIA
  • History of deep venous thrombosis (DVT) and/or pulmonary embolism (PE)
  • Previous episodes of pancreatitis
  • Spinal disorders
  • Chronic pain syndromes
  • History of thrombosis or bleeding disorders
  • Stage III-IV pressure ulcers
  • Sickle cell anemia or other anemia syndromes
  • Monocytosis
  • Thrombocytopenia
  • Diagnosed with fever of unknown origin (FUO)
  • Previously or currently implanted vagus nerve stimulator
  • Previously or currently implanted spinal cord stimulator
  • Other chronically-implanted electronic medical device
  • History of seizures
  • History of cancer
  • Individuals who have taken any of the following medications within two weeks of receiving ultrasound delivery: anti-coagulant, anti-platelet, anti-inflammatory, immunosuppressive agents, alpha and/or beta adrenoceptor blocking agents, anti-seizure medications, anti-diabetic medication
  • Individuals with a substance abuse problem
  • Pregnant women
  • Ascites detected in the abdomen that may effect delivery of shear wave elastroghapy pulse
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    Control Group- Healthy, Lean Individuals

    Determine whether ultrasound exposure at the porta hepatis will affect plasma glucose levels in lean, healthy control subjects.

    Procedure: Ultrasound

  • Active comparator
    Overweight/obese individuals who have normal glucose tolerance or impaired glucose tolerance

    Determine whether three episodes of porta hepatic ultrasound exposure will affect plasma glucose levels as well as insulin sensitivity among overweight/obese individuals who have normal glucose tolerance or impaired glucose tolerance (as defined by OGTT.

    Procedure: Ultrasound

Interventions

  • ProcedureUltrasound

    To determine whether ultrasound exposure at the porta hepatis will affect plasma glucose levels. To also determine whether porta hepatic ultrasound exposure will affect plasma glucose levels as well as insulin sensitivity among overweight/obese individuals who have normal glucose tolerance or impaired glucose tolerance (as defined by OGTT.

06

What researchers measure

Primary outcomes

  1. Insulin Resistance

    Change in OGTT measurements after Hepatic Ultrasound

    Time frame: 1 week

07

Study locations

1 site
  • Yale-New Haven Hospital
    New Haven, Connecticut 06510, United States
08

References and documents

Publications

  • Schwartz GJ. Roles for gut vagal sensory signals in determining energy availability and energy expenditure. Brain Res. 2018 Aug 15;1693(Pt B):151-153. doi: 10.1016/j.brainres.2018.04.004. PubMed 29903617 ↗
  • Cotero V, Fan Y, Tsaava T, Kressel AM, Hancu I, Fitzgerald P, Wallace K, Kaanumalle S, Graf J, Rigby W, Kao TJ, Roberts J, Bhushan C, Joel S, Coleman TR, Zanos S, Tracey KJ, Ashe J, Chavan SS, Puleo C. Noninvasive sub-organ ultrasound stimulation for targeted neuromodulation. Nat Commun. 2019 Mar 12;10(1):952. doi: 10.1038/s41467-019-08750-9. Erratum In: Nat Commun. 2020 Mar 9;11(1):1336. doi: 10.1038/s41467-020-15011-7. PubMed 30862827 ↗

Individual participant data

Plan to share: Yes — Upon request to Principal Investigator de-identified data can be requested.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04622683
Lead sponsor
Yale University
Collaborators
GE Healthcare
Responsible party
Sponsor
First posted
Nov 10, 2020
Start date
Jan 1, 2021
Primary completion
Sep 13, 2023
Completion
Sep 13, 2023
Last update
Dec 16, 2024

Study contacts

Raimund Herzog, MD
principal investigator · Yale University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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