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Fatty Acid Infusion
Low-Dose Fatty Acids for Insulin Resistance (BCAA Trial)
Phase < 1
Recruiting
Led By Zoltan P Arany, MD, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Must not have
History of diabetes
History of diabetes in more than one first-degree relative
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a low dose of fatty acids can cause mild insulin resistance in healthy volunteers, in order to select a dose for future studies.
Who is the study for?
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.
What is being tested?
The trial is testing how a low dose of fatty acids (Intralipid/heparin infusion) affects insulin sensitivity in healthy people to find the right dose that causes mild insulin resistance for future research.
What are the potential side effects?
Potential side effects may include reactions related to the fat infusate due to soy or egg components in Intralipid and possible changes in blood sugar levels leading to mild insulin resistance.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of diabetes.
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More than one of my immediate family members has diabetes.
Select...
My hemoglobin level is below the normal range for my gender.
Select...
My cholesterol or triglycerides levels are high.
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I am allergic to soy or eggs.
Select...
I have severe heart issues, including a recent heart attack or poor heart function.
Select...
I have had pancreatitis before.
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My kidney function is reduced, with an eGFR below 55 ml/min/1.73 m2.
Select...
I have a seizure disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Insulin Sensitivity
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%
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Medium Dose Fatty AcidsExperimental Treatment1 Intervention
Insulin sensitivity (rate of glucose disposal) in response to 60 ml/hr fatty acid infusion
Group II: Low Dose Fatty AcidsExperimental Treatment1 Intervention
Insulin sensitivity (rate of glucose disposal) in response to 30 ml/hr fatty acid infusion
Group III: SalineActive Control1 Intervention
Insulin sensitivity (rate of glucose disposal)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intralipid, 20% Intravenous Emulsion
2018
Completed Phase 4
~200
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,079 Previous Clinical Trials
42,721,609 Total Patients Enrolled
3 Trials studying Insulin Resistance
3,095 Patients Enrolled for Insulin Resistance
Zoltan P Arany, MD, PhDPrincipal InvestigatorAssociate Professor of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of diabetes.You are allergic to metal, specifically aluminum.More than one of my immediate family members has diabetes.My hemoglobin level is below the normal range for my gender.My cholesterol or triglycerides levels are high.You are currently struggling with alcohol or drug abuse.I am allergic to soy or eggs.I am on long-term steroids but take ≤ 5 mg of prednisone daily or its equivalent.I have severe heart issues, including a recent heart attack or poor heart function.Your liver function tests have been consistently higher than normal.Your HbA1c level is higher than 5.7%.I have had pancreatitis before.My kidney function is reduced, with an eGFR below 55 ml/min/1.73 m2.I have a seizure disorder.Your body mass index (BMI) is either too low (less than 19) or too high (more than 27).I am not pregnant, breastfeeding, and I agree to use effective birth control during the study.You have used tobacco in the past year.Your blood pressure is higher than 160 over 100.
Research Study Groups:
This trial has the following groups:- Group 1: Low Dose Fatty Acids
- Group 2: Medium Dose Fatty Acids
- Group 3: Saline
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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