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.

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Key information

Conditions

Healthy Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Procedure

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.

Primary outcomes

Insulin Resistance

Time frame: 1 week

Change in OGTT measurements after Hepatic Ultrasound

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

GE Healthcare

Registry information

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Nov 10, 2020
Registry last updated: Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed