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

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04328337

Enrollment

Registered

2020-03-31

Start date

2020-12-08

Completion date

2026-06-01

Last updated

2025-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

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

DRUGIntralipid, 20% Intravenous Emulsion

Infusion of Intralipid 20%

DRUGPlacebos

saline 30 ml/hr for 12 hours through an IV

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change in brain glucose transport capacity	Through End of Study (Up to 12 hours)	Measurement of brain glucose transport rates using magnetic resonance spectroscopy (MRS).

Countries

United States

Contacts

Primary ContactJoseph Palmiotto

joseph_palmiotto@med.unc.edu919-966-9184

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026