Fatty Acid Interventions for Insulin Resistance
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how different types of fats might affect insulin resistance in muscles, a condition linked to obesity and Type 2 diabetes. Researchers are testing two treatments: one with palm oil and another with a fat mixture called Intralipid (a 20% fat emulsion), both compared to a saline solution. The goal is to determine how these fats alter the way muscles process fatty acids and insulin. Individuals who are not obese, maintain a stable weight, and do not smoke heavily may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to foundational research that could lead to new insights into managing insulin resistance.
Will I have to stop taking my current medications?
The trial requires that you stop taking medications that can alter your serum lipid profile, such as high dose fish oil, statins, niacin, fibrates, thiazolinediones, beta-blockers, and atypical antipsychotics.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have examined the safety of both Intralipid and palm oil emulsion, revealing some clear findings. Intralipid, a fat mixture administered through an IV, is generally well-tolerated but can raise blood pressure. It should be used cautiously in individuals with certain health issues, such as liver damage or poorly controlled diabetes.
Conversely, palm oil emulsion has been shown to affect insulin usage in the body, potentially leading to insulin resistance. This may make it harder for the body to use insulin effectively, possibly resulting in higher blood sugar levels.
Both treatments have known effects and specific risks. Prospective trial participants should consider these factors and discuss any concerns with health professionals.12345Why are researchers excited about this trial?
Researchers are excited about these treatments for insulin resistance because they explore new ways of using fatty acids to manage the condition. Unlike traditional medications that often rely on improving insulin sensitivity through oral drugs or injections, Intralipid and Palm Oil Emulsion offer a novel approach by directly influencing the lipid metabolism. This could potentially provide a more targeted way to combat insulin resistance. By utilizing these fatty acid interventions, there's hope for a different pathway that could lead to better management of insulin levels in the body.
What evidence suggests that this trial's treatments could be effective for insulin resistance?
This trial will compare the effects of Intralipid and palm oil on insulin resistance. Studies have shown that increasing free fatty acids (FFAs) with Intralipid reduces muscle responsiveness to insulin, meaning the body doesn't use insulin as effectively. Research suggests that an Intralipid infusion alters fat processing in the body, potentially leading to insulin resistance. Meanwhile, palm oil interferes with insulin's ability to function in certain tissues, which could also cause insulin resistance. Current evidence indicates that both Intralipid and palm oil, tested in separate arms of this trial, can affect how the body handles fatty acids, potentially impacting insulin function and muscle sugar absorption.35678
Who Is on the Research Team?
Michael D Jensen, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for healthy, non-obese adults with a BMI of 18-27 who are not pregnant or nursing and have maintained their weight. Women must be premenopausal. It excludes those on certain lipid-altering meds, smokers, individuals with specific heart diseases or lidocaine allergy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-clamp
Volunteers receive an intravenous infusion of C13-labelled palmitate as a tracer for enrichment calculations pre-clamp. One muscle biopsy is obtained.
Insulin Clamp
Volunteers receive an intravenous infusion of a second tracer, D-9 palmitate, to calculate enrichments during the insulin clamp stage. A second muscle biopsy is performed.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Intralipid
- Palm Oil Emulsion
- Saline
Intralipid is already approved in United States, European Union, Canada for the following indications:
- Parenteral nutrition
- Caloric supplementation
- Parenteral nutrition
- Caloric supplementation
- Parenteral nutrition
- Caloric supplementation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator