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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 belowSelect...
My BMI is over 30.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My high blood pressure is not under control.
Select...
I am not pregnant, trying to get pregnant, or breastfeeding.
Select...
I have a known liver, stomach, kidney, brain, mental health, or stroke-related condition.
Select...
I have used steroids in the last 6 months.
Select...
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)
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 • NCT0067285422%
Bacteremia
14%
Urinary tract infection,
10%
Cardiac arrhythmia,
10%
Pneumonia
8%
Wound infection,
4%
Vein irritation
2%
Congestive heart failure,
100%
80%
60%
40%
20%
0%
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
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.
Patient involvement to inform the design of a clinical trial in postbariatric hypoglycaemia.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,929 Previous Clinical Trials
3,032,856 Total Patients Enrolled
60 Trials studying Obesity
248,512 Patients Enrolled for Obesity
University of North Carolina, Chapel HillLead Sponsor
1,565 Previous Clinical Trials
4,301,487 Total Patients Enrolled
66 Trials studying Obesity
58,660 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,459 Previous Clinical Trials
4,336,157 Total Patients Enrolled
471 Trials studying Obesity
590,924 Patients Enrolled for Obesity
Janice Hwang, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
2 Previous Clinical Trials
45 Total Patients Enrolled
Janice Jin Hwang, MD, MHSPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 45 years old.My high blood pressure is not under control.I am not pregnant, trying to get pregnant, or breastfeeding.My BMI is over 30.My weight has changed by more than 5% in the last 6 months.I have a known liver, stomach, kidney, brain, mental health, or stroke-related condition.I have used steroids in the last 6 months.I am not taking any drugs or supplements that affect brain metabolism or fats.My BMI is over 30.
Research Study Groups:
This trial has the following groups:- Group 1: Non-diabetic, normal weight individuals receiving Intralipid
- Group 2: Non-diabetic, normal weight individuals receiving saline
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.