Clinical trial NCT04622683: Effects of Hepatic Ultrasound on Metabolic Homeostasis
Official title: Effects of Hepatic Ultrasound on Metabolic Homeostasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Insulin Resistance
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2020-11-10
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Insulin Resistance
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Raimund Herzog, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.