Effects of Hepatic Ultrasound on Metabolic Homeostasis

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Insulin Resistance
• Intervention / Treatment: Procedure: Ultrasound

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale-New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin Resistance	Change in OGTT measurements after Hepatic Ultrasound	1 week

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: GE Healthcare
• Investigators: Principal Investigator: Raimund Herzog, MD, Yale University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): September 13, 2023
• Study Completion (Actual): September 13, 2023

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: 2000026135; 1R01DK131127-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon request to Principal Investigator de-identified data can be requested.
• IPD Sharing Time Frame: Dependent upon request.
• IPD Sharing Access Criteria: Email to Principal Investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No