NCT04328337 · University of North Carolina, Chapel Hill
Investigating Whether Acute Elevation of Fatty Acid Levels Alters Cerebral Glucose Transport and Metabolism
What this study is about
The goal of this study is to understand the role of brain glucose transport in individuals with obesity and the association with cerebral hypometabolism and these individuals' response to plasma glucose elevations. The main premise is that obesity leads to reduced brain glucose transport and that we can measure this reduction with magnetic resonance spectroscopy (MRS).
View original scientific description
The goal of this study is to understand the role of brain glucose transport in individuals with obesity and the association with cerebral hypometabolism and these individuals' response to plasma glucose elevations. The main premise is that obesity leads to reduced brain glucose transport and that we can measure this reduction with magnetic resonance spectroscopy (MRS).
Interventions
DRUG
Intralipid, 20% Intravenous Emulsion
Infusion of Intralipid 20%
DRUG
Placebos
saline 30 ml/hr for 12 hours through an IV
Primary outcome measures
Change in brain glucose transport capacity
Time frame: Through End of Study (Up to 12 hours)
Measurement of brain glucose transport rates using magnetic resonance spectroscopy (MRS).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 18-45 years
- HbA1C \<6.5%
- Normal weight individuals: BMI 17-25 kg/m\^2
- Obese individuals: BMI \>30 kg/m\^2
Exclusion criteria
- Creatinine \>1.5mg/dL
- Hematocrit \<35% for females and \<39% for males
- ALT and AST \>2.5X upper limit of normal
- Abnormal TSH
- Abnormal PT/PTT/INR
- Triglycerides \>200 mg/dL
- Known hepatic, gastrointestinal, renal, neurologic, psychiatric, cerebrovascular disease
- Uncontrolled hypertension
- Current or past 3 months use of ketogenic diet
- Use of any medications, vitamins, or supplements that can alter cerebral metabolism or lipids
- Current or recent steroid use in last 6 months
- \>5% body weight change in last 6 months
- Illicit drug use/alcoholism
- Inability to enter MRI/MRS
- For women: pregnancy, seeking pregnancy, or breastfeeding
Where
- Chapel Hill, North Carolina
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 30, 2025 · Source of record for eligibility and locations