Effects of Hepatic Ultrasound on Metabolic Homeostasis

Not Applicable

Completed

• Conditions: Insulin Resistance; Healthy
• Interventions: Procedure: Ultrasound

• Registration Number: NCT04622683
• Lead Sponsor: Yale University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-10
• Study Start: 2021-01-01
• Primary Completion: 2023-09-13
• Study Completion: 2023-09-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group- Healthy, Lean Individuals	Ultrasound	Determine whether ultrasound exposure at the porta hepatis will affect plasma glucose levels in lean, healthy control subjects.
Overweight/obese individuals who have normal glucose tolerance or impaired glucose tolerance	Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Insulin Resistance	1 week	Change in OGTT measurements after Hepatic Ultrasound

Trial Locations

Locations (1)

Yale-New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States