Effects of Hepatic Ultrasound on Metabolic Homeostasis

NCT04622683 | Completed DMC

• 1 other identifier: 2000026135
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Insulin Resistance

  Change in OGTT measurements after Hepatic Ultrasound

  1 week

Study Arms (2)

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

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.

Control Group- Healthy, Lean Individuals; Overweight/obese individuals who have normal glucose tolerance or impaired glucose tolerance

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• GE Healthcare: collaborator

Study Sites (1)

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Related Publications (2)

• 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.

  PMID: 29903617 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.

  PMID: 30862827 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Raimund Herzog, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 10, 2020
• Study Start: January 1, 2021
• Primary Completion: September 13, 2023
• Study Completion: September 13, 2023
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Dependent upon request.
• Access Criteria: Email to Principal Investigator

Locations

US (1)