Fatty Acid Elevation for Obesity
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any medications, vitamins, or supplements that can alter brain metabolism or lipids to participate in this trial.
Is the treatment generally safe for humans?
How is the treatment Intralipid 20% IV Fat Emulsion unique for obesity?
Intralipid 20% IV Fat Emulsion is unique for obesity as it involves intravenous administration of a fat emulsion, which increases free fatty acid levels in the blood, potentially affecting blood pressure and endothelial function. This approach is different from typical oral medications or lifestyle interventions for obesity.56789
What data supports the effectiveness of the treatment Intralipid 20% for obesity?
Who Is on the Research Team?
Janice Jin Hwang, MD, MHS
Principal Investigator
University of North Carolina, Chapel Hill
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive an infusion of either Intralipid or normal saline for 12 hours
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Intralipid, 20% Intravenous Emulsion
- Placebos
Intralipid, 20% Intravenous Emulsion is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
University of North Carolina, Chapel Hill
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator