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Effects of Hepatic Ultrasound on Metabolic Homeostasis

Primary Purpose

Healthy, Insulin Resistance

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yale-New Haven HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Control Group- Healthy, Lean Individuals

Overweight/obese individuals who have normal glucose tolerance or impaired glucose tolerance

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Insulin Resistance
Change in OGTT measurements after Hepatic Ultrasound

Secondary Outcome Measures

Full Information

First Posted
November 2, 2020
Last Updated
August 22, 2023
Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04622683
Brief Title
Effects of Hepatic Ultrasound on Metabolic Homeostasis
Official Title
Effects of Hepatic Ultrasound on Metabolic Homeostasis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Insulin Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group- Healthy, Lean Individuals
Arm Type
Experimental
Arm Description
Determine whether ultrasound exposure at the porta hepatis will affect plasma glucose levels in lean, healthy control subjects.
Arm Title
Overweight/obese individuals who have normal glucose tolerance or impaired glucose tolerance
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Insulin Resistance
Description
Change in OGTT measurements after Hepatic Ultrasound
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alice Hahn
Phone
475-321-0504
Email
diabetes.research@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raimund Herzog, MD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Janice Hwang, MD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Hahn
Phone
475-321-0504
Email
diabetes.research@yale.edu

12. IPD Sharing Statement

Citations:
PubMed Identifier
29903617
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.
Results Reference
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PubMed Identifier
30862827
Citation
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.
Results Reference
background

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Effects of Hepatic Ultrasound on Metabolic Homeostasis

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