What side effects are associated with this type of intervention?

Common treatments for insulin resistance include metformin, thiazolidinediones, and lifestyle interventions. Metformin is often associated with gastrointestinal side effects such as nausea, diarrhea, and abdominal discomfort. Thiazolidinediones, like rosiglitazone and pioglitazone, can cause weight gain, fluid retention, increased risk of heart failure, and bone fractures. Lifestyle interventions, including diet and exercise, generally have fewer side effects but can be challenging to maintain long-term. Each treatment has its own risk-benefit profile, which should be considered in consultation with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of insulin resistance, primarily focusing on insulin sensitizers and GLP-1 receptor agonists. Insulin sensitizers like metformin and thiazolidinediones (e.g., rosiglitazone) improve the body's response to insulin. GLP-1 receptor agonists, such as liraglutide and semaglutide, enhance insulin secretion and have additional benefits like weight loss and improved lipid profiles. These treatments aim to achieve better glycemic control and are similar to the therapeutic goals being explored in studies involving ultrasound exposure for modulating glucose homeostasis and insulin resistance.

What other types of research exist?

Promising novel alternatives for treating insulin resistance in 2024 include: 1) Lifestyle interventions such as intensive diet and exercise programs, which have shown significant benefits in managing insulin resistance and type 2 diabetes. 2) Pharmacological treatments like metformin, which is widely used for its efficacy in improving insulin sensitivity. 3) Newer agents such as GLP-1 receptor agonists (e.g., semaglutide) and SGLT2 inhibitors (e.g., empagliflozin), which have demonstrated positive effects on glucose homeostasis and cardiovascular outcomes. 4) Investigational drugs like FGF21 analogues (e.g., pegbelfermin) that target metabolic pathways and show promise in early trials. 5) Non-pharmacological approaches like bariatric surgery for eligible patients, which can lead to significant improvements in insulin sensitivity and metabolic health.

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Procedure

Hepatic Ultrasound for Metabolic Homeostasis in Healthy Subjects

Q: What is the mechanism of action of this treatment?

Common treatments for insulin resistance include lifestyle interventions, pharmacological treatments, and novel approaches like ultrasound exposure. Lifestyle interventions, such as diet and exercise, improve insulin sensitivity by reducing body fat and enhancing glucose uptake by muscles. Pharmacological treatments, like metformin, decrease hepatic glucose production and increase peripheral glucose uptake. GLP-1 receptor agonists and SGLT2 inhibitors improve insulin sensitivity by enhancing insulin secretion and reducing glucose reabsorption in the kidneys, respectively. Novel approaches, such as ultrasound exposure to the liver, may modulate glucose homeostasis by affecting insulin signaling pathways. These mechanisms are crucial for insulin resistance patients as they help maintain blood glucose levels, reduce the risk of diabetes complications, and improve overall metabolic health.

N/A

Waitlist Available

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

Must not have

Diagnosed with fever of unknown origin (FUO)

Stage III-IV pressure ulcers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week

Awards & highlights

No Placebo-Only Group

Summary

This trial uses sound waves on a specific part of the liver to see if it affects blood sugar and insulin 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.

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.

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 below

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I am a healthy person with a BMI under 24 and normal blood sugar levels.

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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a fever whose cause is unknown.

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I have a severe skin ulcer.

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I have a history of blood clots or bleeding problems.

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I have had a deep vein clot or a lung clot in the past.

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I have had a stroke or a mini-stroke (TIA) before.

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I have had surgery on my spleen, esophagus, lungs, stomach, duodenum, or liver.

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I have not had surgery in the last 3 months.

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I have had leukemia or lymphoma in the past.

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I suffer from long-term pain.

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I haven't taken blood thinners, immune suppressants, or specific heart, seizure, and diabetes medications in the last 2 weeks.

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I have diabetes.

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I have had cancer in the past.

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I have a spinal disorder.

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I have rheumatoid arthritis or another immune-mediated disease.

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I am living with HIV/AIDS.

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I have end-stage kidney disease or uremia.

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I have had pancreatitis before.

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I have recently had a serious injury, including brain bleeding.

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I currently have cancer.

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I have a low platelet count.

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I have a history of seizures.

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I have sickle cell anemia or another type of anemia.

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I have a history of heart issues, including angina, heart attack, or heart surgery.

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I have a heart rhythm problem such as atrial fibrillation or ventricular arrhythmias.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insulin Resistance

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~4090

0 / 26Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for insulin resistance include lifestyle interventions, pharmacological treatments, and novel approaches like ultrasound exposure. Lifestyle interventions, such as diet and exercise, improve insulin sensitivity by reducing body fat and enhancing glucose uptake by muscles. Pharmacological treatments, like metformin, decrease hepatic glucose production and increase peripheral glucose uptake. GLP-1 receptor agonists and SGLT2 inhibitors improve insulin sensitivity by enhancing insulin secretion and reducing glucose reabsorption in the kidneys, respectively. Novel approaches, such as ultrasound exposure to the liver, may modulate glucose homeostasis by affecting insulin signaling pathways. These mechanisms are crucial for insulin resistance patients as they help maintain blood glucose levels, reduce the risk of diabetes complications, and improve overall metabolic health.