Effects of Hepatic Ultrasound on Metabolic Homeostasis

Healthy Clinical Trial

Official title:

Effects of Hepatic Ultrasound on Metabolic Homeostasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04622683
• Other study ID #: 2000026135
• Secondary ID: 1R01DK131127-01A
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: May 2024

Study information

• Verified date: August 2023
• Source: Yale University
• Contact: Alice Hahn
• Phone: 475-321-0504
• Email: diabetes.research[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Insulin Resistance

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Yale-New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Erratum In: Nat Commun. 2020 Mar 9;11(1):1336. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Resistance	Change in OGTT measurements after Hepatic Ultrasound	1 week