Clinical trial

Investigating Whether Acute Elevation of Fatty Acid Levels Alters Cerebral Glucose Transport and Metabolism

Recruiting now · Phase 1, Phase 2 · 1 countries · Registry ID NCT04328337

Recruiting nowPhase 1, Phase 2Interventional

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). 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 45 Years

SexAll

Healthy volunteersAccepted

ConditionObesity

Full registry 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

Treatments and study arms

Intralipid, 20% Intravenous Emulsion

Drug

Infusion of Intralipid 20%

Placebos

Drug

saline 30 ml/hr for 12 hours through an IV

Primary outcomes

Change in brain glucose transport capacityThrough End of Study (Up to 12 hours)

Measurement of brain glucose transport rates using magnetic resonance spectroscopy (MRS).

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Biomedical Research Imaging Center Marsico Hall (UNC)🇺🇸 Chapel Hill, North Carolina, United States

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Joseph PalmiottoContact

Email · Call 919-966-9184

Clinical and Translational Research Center (CTRC) Burnett-Womack Building (UNC)🇺🇸 Chapel Hill, North Carolina, United States

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Joseph PalmiottoContact

Email · Call 919-966-9184