Effects of Hepatic Ultrasound on Metabolic Homeostasis | NCT04622683

NCT04622683

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
GE Healthcare	INDUSTRY

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

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

Eligibility Module

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

Name	Affiliation	Role
Raimund Herzog, MD	Yale University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Yale-New Haven Hospital		New Haven	Connecticut	06510	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29903617	Background	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.
30862827	Background	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.

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D000069453	Ultrasonic Waves
D013016	Sound
D011840	Radiation, Nonionizing
D011827	Radiation