Low-Dose Fatty Acids for Insulin Resistance
(BCAA Trial)
Trial Summary
What is the purpose of this trial?
The primary goal of this study is to determine the dose of fatty acids that acutely induces mild insulin resistance in healthy volunteers. We hypothesize that a low-dose of fatty acid infusion (Intralipid/heparin) will cause a mild insulin resistance. The dose of fatty acid infusion that reliably causes mild insulin resistance will be selected for use in future studies.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on systemic steroids, you may need to adjust your dose to 5 mg of prednisone daily or an equivalent dose of hydrocortisone.
What data supports the effectiveness of the treatment Intralipid for insulin resistance?
Is the use of low-dose fatty acids, like Intralipid, generally safe for humans?
Intralipid, a type of fat emulsion, has been used safely in humans for over 40 years, primarily as a nutritional supplement. Studies show it is generally well-tolerated, but caution is advised in severely ill patients due to potential metabolic effects like increased fat levels in the blood. Newer formulations with alternative oils, such as fish oil, may offer additional safety benefits.36789
How does the drug Intralipid differ from other treatments for insulin resistance?
Intralipid is unique because it is a fat emulsion that can be used to deliver fatty acids intravenously, potentially affecting insulin resistance by altering free fatty acid levels and promoting glucose conservation. Unlike typical oral medications for insulin resistance, Intralipid is administered directly into the bloodstream, which may lead to different metabolic effects.1341011
Eligibility Criteria
Healthy volunteers who can consent and follow study procedures, without soy or egg allergies, severe heart disease, kidney issues, high cholesterol/triglycerides, diabetes history in family, BMI between 19-27 kg/m2. Must not have used investigational drugs recently or have certain chronic diseases.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a 6-hour hyperinsulinemic-euglycemic clamp with low-dose fatty acid infusion (30ml/hr) to test insulin sensitivity
Dose Confirmation
If initial low-dose does not achieve desired insulin resistance, participants return for another 6-hour clamp with medium-dose fatty acid infusion (60ml/hr)
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Intralipid (Fatty Acid Infusion)
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