Understanding how fatty acids affect brain glucose transport in obesity
Investigating Whether Acute Elevation of Fatty Acid Levels Alters Cerebral Glucose Transport and Metabolism
This study is testing how fatty acids affect the way the brain uses sugar in people with obesity compared to those of normal weight.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 2 sites (Chapel Hill, North Carolina and 1 other locations) |
| Trial ID | NCT04328337 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the impact of obesity on glucose transport and metabolism in the brain, focusing on the role of elevated non-esterified fatty acids (NEFAs). It includes two main aims: the first involves comparing glucose transport in non-diabetic obese individuals with matched normal weight individuals using magnetic resonance spectroscopy (MRS). The second aim randomizes normal weight individuals to receive either intralipid or saline to assess how acute NEFA elevation influences cerebral glucose transport.
Who should consider this trial
Good fit: Ideal candidates include non-diabetic individuals aged 18-45 with either a normal weight (BMI 17-25 kg/m²) or obesity (BMI >30 kg/m²).
Not a fit: Patients with significant metabolic or neurological disorders, recent weight changes, or those on specific medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new insights into metabolic dysfunction in obesity and potential therapeutic targets for improving brain glucose metabolism.
How similar studies have performed: While the specific approach of this study is novel, related studies have explored the effects of fatty acids on metabolism, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * Smoking * 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 this trial is running
Chapel Hill, North Carolina and 1 other locations
- Biomedical Research Imaging Center Marsico Hall (UNC) — Chapel Hill, North Carolina, United States (Recruiting)
- Clinical and Translational Research Center (CTRC) Burnett-Womack Building (UNC) — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Janice Jin Hwang, MD, MHS — University of North Carolina, Chapel Hill
- Study coordinator: Joseph Palmiotto
- Email: joseph_palmiotto@med.unc.edu
- Phone: 919-966-9184
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.