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Procedure
Hepatic Ultrasound for Metabolic Homeostasis in Healthy Subjects
N/A
Recruiting
Led By Raimund Herzog, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
18 - 60 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week
Awards & highlights
Study Summary
This trial is looking at the effects of ultrasound on the liver and glucose levels in healthy people.
Who is the study for?
This trial is for healthy adults aged 18-60 with a BMI under 24, or overweight/obese individuals with a BMI of 25-35. Participants must have normal blood glucose levels. Excluded are those with diabetes, heart devices like pacemakers, recent surgeries or injuries, cancer history, clotting disorders, chronic pain syndromes, certain medication use within two weeks prior to the study and pregnant women.Check my eligibility
What is being tested?
The trial investigates how ultrasound exposure on the liver affects blood sugar control and insulin resistance in healthy people as well as those who are overweight or obese. It aims to understand if this non-invasive procedure can influence metabolic processes.See study design
What are the potential side effects?
While not explicitly stated in the provided information, potential side effects from hepatic ultrasound may include discomfort at the site of application or mild bruising; however these are generally minimal since ultrasound is considered safe and non-invasive.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a healthy person with a BMI under 24 and normal blood sugar levels.
Select...
I am between 18 and 60 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Insulin Resistance
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Control Group- Healthy, Lean IndividualsExperimental Treatment1 Intervention
Determine whether ultrasound exposure at the porta hepatis will affect plasma glucose levels in lean, healthy control subjects.
Group II: Overweight/obese individuals who have normal glucose tolerance or impaired glucose toleranceActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound
2013
Completed Phase 1
~1950
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,531 Total Patients Enrolled
87 Trials studying Insulin Resistance
13,165 Patients Enrolled for Insulin Resistance
Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,381 Total Patients Enrolled
26 Trials studying Insulin Resistance
5,351 Patients Enrolled for Insulin Resistance
Raimund Herzog, MDPrincipal InvestigatorYale School of Medicine
5 Previous Clinical Trials
118 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a device called a vagus nerve stimulator implanted before or currently.I have been diagnosed with a fever whose cause is unknown.I am a healthy person with a BMI under 24 and normal blood sugar levels.I have a severe skin ulcer.I have a history of blood clots or bleeding problems.I have had a deep vein clot or a lung clot in the past.I have had a stroke or a mini-stroke (TIA) before.I have had surgery on my spleen, esophagus, lungs, stomach, duodenum, or liver.I have not had surgery in the last 3 months.I have had leukemia or lymphoma in the past.I suffer from long-term pain.I haven't taken blood thinners, immune suppressants, or specific heart, seizure, and diabetes medications in the last 2 weeks.I have diabetes.Participants who are overweight or obese with a BMI between 25 and 35 kg/m2.I have had cancer in the past.I have a spinal disorder.You have a problem with drugs or alcoholYou have another electronic medical device that has been implanted for a long time.I have rheumatoid arthritis or another immune-mediated disease.I have fluid in my abdomen that might interfere with certain medical tests.I am living with HIV/AIDS.I am between 18 and 60 years old.You have had a spinal cord stimulator implanted in the past or currently have one.I have end-stage kidney disease or uremia.I have had pancreatitis before.I have recently had a serious injury, including brain bleeding.I currently have cancer.I have a low platelet count.I have a history of seizures.I have sickle cell anemia or another type of anemia.I have a history of heart issues, including angina, heart attack, or heart surgery.High levels of monocytes in the blood.I have a heart rhythm problem such as atrial fibrillation or ventricular arrhythmias.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group- Healthy, Lean Individuals
- Group 2: Overweight/obese individuals who have normal glucose tolerance or impaired glucose tolerance
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Insulin Resistance Patient Testimony for trial: Trial Name: NCT04622683 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the highest number of individuals participating in this medical trial?
"Affirmative. The clinicaltrials.gov website shows that this trial is actively seeking participants, and was initially posted on January 1st 2021 with the last update occurring come March 11th 2022. Currently they are looking to recruit 60 patients from one location."
Answered by AI
What types of individuals are being sought out to participate in this experiment?
"To be deemed eligible for this trial, applicants must possess insulin resistance and lie within the age range of 18 to 60. The study is looking to enrol approximately sixty individuals in total."
Answered by AI
Is there still capacity for individuals to join the trial?
"Affirmative. According to information on clinicaltrials.gov, this medical trial is actively recruiting and was initially advertised on January 1st 2021 with the most recent edit occurring on March 11th 2022. This clinical trial requires 60 participants from a single site."
Answered by AI
Does this research endeavour accept elderly participants?
"This medical trial is currently enrolling patients who are aged 18 and older, but no more than 60 years old."
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
Nevada
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Yale-New Haven Hospital
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Just looking to help and dad had diabetes.
PatientReceived 1 prior treatment
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