Effects of Hepatic Ultrasound on Metabolic Homeostasis

Yale University

Status: Completed

Conditions: Healthy; Insulin Resistance

Treatments: Procedure: Ultrasound

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04622683

2000026135

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Control Group- Healthy, Lean Individuals

Experimental group

Description:

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

Treatment:

Procedure: Ultrasound

Overweight/obese individuals who have normal glucose tolerance or impaired glucose tolerance

Active Comparator group

Description:

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.

Treatment:

Procedure: Ultrasound