Effects of Hepatic Ultrasound on Metabolic Homeostasis

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Hepatic Ultrasound on Metabolic Homeostasis

Conditions
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Healthy, Insulin Resistance

Intervention / Treatment
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* Procedure: Ultrasound


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control Group- Healthy, Lean Individuals<br>Determine whether ultrasound exposure at the porta hepatis will affect plasma glucose levels in lean, healthy control subjects. | Procedure: Ultrasound<br>* 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.<br>|
| Active Comparator: Overweight/obese individuals who have normal glucose tolerance or impaired glucose tolerance<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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