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Effects of Hepatic Ultrasound on Metabolic Homeostasis

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04622683
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
27.9
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ultrasound
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Hepatic Ultrasound on Metabolic Homeostasis
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Control Group- Healthy, Lean Individuals

Determine whether ultrasound exposure at the porta hepatis will affect plasma glucose levels in lean, healthy control subjects.

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.
Active Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Insulin Resistance [1 week]

    Change in OGTT measurements after Hepatic Ultrasound

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yale-New Haven Hospital New Haven Connecticut United States 06510

Sponsors and Collaborators

  • Yale University

Investigators

  • Principal Investigator: Raimund Herzog, MD, Yale School of Medicine
  • Principal Investigator: Janice Hwang, MD, Yale School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT04622683
Other Study ID Numbers:
  • 2000026135
First Posted:
Nov 10, 2020
Last Update Posted:
Mar 14, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Insulin Resistance

Study Results

No Results Posted as of Mar 14, 2022