Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2021-01-01
2023-09-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Control Group- Healthy, Lean Individuals
Determine whether ultrasound exposure at the porta hepatis will affect plasma glucose levels in lean, healthy control subjects.
Ultrasound
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.
Overweight/obese individuals who have normal glucose tolerance or impaired glucose tolerance
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.
Ultrasound
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.
Interventions
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Ultrasound
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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GE Healthcare
INDUSTRY
Yale University
OTHER
Responsible Party
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Principal Investigators
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Raimund Herzog, MD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale-New Haven Hospital
New Haven, Connecticut, United States
Countries
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References
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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.
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.
Other Identifiers
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2000026135
Identifier Type: -
Identifier Source: org_study_id