Investigating Whether Acute Elevation of Fatty Acid Levels Alters Cerebral Glucose Transport and Metabolism
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intralipid, 20% Intravenous Emulsion, Placebos.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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). The secondary premises are that this reduction is driven by elevated non esterified fatty acids which act to turn on specific signaling pathways that regulate brain GLUT1 levels.
Detailed description
There are 2 aims of this study. The intent of aim 1 is to measure the effect of obesity on glucose transport and metabolism in the human brain. This study aim will be conducted in non-diabetic, obese individuals and age- and HbA1c-matched normal weight individuals. A total of 15 non-diabetic - normal weight individuals and 15 obese individuals will be enrolled.
The second aim randomizes 40 non-diabetic, normal weight individuals. The intent of aim 2 is to determine whether acute elevation of NEFA levels in lean, healthy individuals will alter cerebral glucose transport. Eligible participants will be randomized (1:1) to receive either intralipid or normal saline.
The focus of this protocol registration is the randomized portion of the study (aim 2).
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)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 2 centers
- Biomedical Research Imaging Center Marsico Hall (UNC) — Chapel Hill
- Clinical and Translational Research Center (CTRC) Burnett-Womack Building (UNC) — Chapel Hill
Identifiers
NCT: NCT04328337 · 22-2455 · 1R01DK123227-01