What side effects are associated with this type of intervention?

Common treatments for obesity, such as GLP-1 receptor agonists like liraglutide, can cause side effects including gastrointestinal issues (nausea, vomiting, diarrhea), and in some cases, pancreatitis. Metformin, another common treatment, often causes gastrointestinal discomfort, including diarrhea and nausea. Topiramate may lead to cognitive side effects like memory issues and difficulty concentrating, as well as paresthesia (tingling sensations). Antipsychotic medications, particularly atypical ones, can lead to significant weight gain, metabolic syndrome, and increased risk of diabetes.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including GLP-1 receptor agonists such as liraglutide (brand name: Saxenda) and semaglutide (brand name: Wegovy). These medications have shown efficacy in promoting weight loss and improving glycemic control. Liraglutide was initially approved for type 2 diabetes under the brand name Victoza and later for obesity management. Semaglutide, also used for type 2 diabetes under the brand name Ozempic, received approval for obesity treatment due to its significant weight loss benefits. These drugs work by mimicking the incretin hormone GLP-1, which helps regulate appetite and food intake.

What other types of research exist?

Promising novel alternatives to Magnetic Resonance Spectroscopy (MRS) for measuring brain glucose transport in obesity patients include advanced PET imaging techniques, such as amyloid PET, and quantitative EEG. Additionally, investigational biomarkers like alpha-synuclein deposition in peripheral tissues are being explored.

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Fatty Acid Elevation for Obesity

Phase 1 & 2

Recruiting

Led By Janice Hwang, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Obese individuals: BMI >30 kg/m^2

Be between 18 and 65 years old

Must not have

Uncontrolled hypertension

For women: pregnancy, seeking pregnancy, or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through end of study (up to 12 hours)

Summary

This trial involves giving healthy individuals either a fat solution or a saltwater solution to see how it affects their brain's ability to transport glucose. The study focuses on non-diabetic, normal weight people to understand how sudden increases in blood fatty acids impact brain energy use. Researchers hope to learn more about brain glucose transport in relation to obesity.

Who is the study for?

This trial is for adults aged 18-45 with obesity (BMI >30 kg/m2) or normal weight (BMI 17-25 kg/m2), and HbA1C levels below 6.5%. Participants should not have significant health issues like liver, kidney, or heart diseases, uncontrolled high blood pressure, abnormal thyroid or clotting tests, recent drastic weight changes, substance abuse problems, or be pregnant/breastfeeding.

What is being tested?

The study aims to understand how brain glucose transport is affected in obese individuals by temporarily raising fatty acid levels using Intralipid. A placebo group will serve as a comparison. The effects on brain metabolism are monitored through magnetic resonance spectroscopy (MRS).

What are the potential side effects?

Intralipid may cause reactions at the infusion site such as redness and pain; allergic reactions including rash and difficulty breathing; and changes in blood fat levels which can affect overall health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is over 30.

Exclusion Criteria

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

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My high blood pressure is not under control.

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I am not pregnant, trying to get pregnant, or breastfeeding.

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I have a known liver, stomach, kidney, brain, mental health, or stroke-related condition.

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I have used steroids in the last 6 months.

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I am not taking any drugs or supplements that affect brain metabolism or fats.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through end of study (up to 12 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through end of study (up to 12 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through end of study (up to 12 hours) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in brain glucose transport capacity

Side effects data

From 2010 Phase 2 & 3 trial • 100 Patients • NCT00672854

22%

Bacteremia

14%

Urinary tract infection,

10%

Cardiac arrhythmia,

10%

Pneumonia

Wound infection,

Vein irritation

Congestive heart failure,

100%

80%

60%

40%

20%

Study treatment Arm

Total Parenteral Nutrition (TPN) Given Intralipid 20%

Total Parenteral Nutrition (TPN) Given ClinOleic 20%

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Non-diabetic, normal weight individuals receiving IntralipidExperimental Treatment1 Intervention

Non-diabetic, normal weight individuals receiving Intralipid. Participants will receive an infusion of Intralipid 20% for 12 hours through an IV (prior to and during scan #2)

Group II: Non-diabetic, normal weight individuals receiving salinePlacebo Group1 Intervention

Non-diabetic, normal weight individuals receiving saline. Participants will receive an infusion of normal saline (1:1 randomization) at 30 ml/hr for 12 hours through an IV (prior to and during scan #2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intralipid, 20% Intravenous Emulsion

2018

Completed Phase 4

~200

0 / 6Eligibility 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 obesity include lifestyle interventions, pharmacotherapy, and bariatric surgery. Lifestyle interventions focus on diet and physical activity to reduce caloric intake and increase energy expenditure. Pharmacotherapy, such as GLP-1 receptor agonists (e.g., liraglutide, semaglutide), works by enhancing satiety and reducing appetite, leading to lower food intake. Bariatric surgery, including procedures like gastric bypass and sleeve gastrectomy, physically restricts stomach size and alters gut hormones to reduce hunger and improve insulin sensitivity. These treatments are crucial for obesity patients as they not only aid in weight loss but also improve metabolic health, potentially enhancing brain glucose transport and reducing the risk of cerebral hypometabolism, which is significant for overall cognitive function and quality of life.

Patient involvement to inform the design of a clinical trial in postbariatric hypoglycaemia.