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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT04328337
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Intralipid, 20% Intravenous Emulsion — DRUG
    Infusion of Intralipid 20%
  • Placebos — DRUG
    saline 30 ml/hr for 12 hours through an IV

Study Details

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.

Key Dates

Start date
Dec 8, 2020
Status verified
Mar 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Non-diabetic, normal weight individuals receiving Intralipid
    Non-diabetic, normal weight individuals receiving Intralipid. Participants will receive an infusion of Intralipid 20% for 12 hours through an IV (prior to and during scan #2)
  • Placebo Comparator: Non-diabetic, normal weight individuals receiving saline
    Non-diabetic, normal weight individuals receiving saline. Participants will receive an infusion of normal saline (1:1 randomization) at 30 ml/hr for 12 hours through an IV (prior to and during scan #2

Primary Outcome Measure

Change in brain glucose transport capacity [ Time Frame: Through End of Study (Up to 12 hours) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Biomedical Research Imaging Center Marsico Hall (UNC)Chapel HillNorth Carolina27514
Joseph Palmiotto
[email protected]
919-966-9184
Clinical and Translational Research Center (CTRC) Burnett-Womack Building (UNC)Chapel HillNorth Carolina27514
Joseph Palmiotto
[email protected]
919-966-9184

Find similar trials in Chapel Hill, NC

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Biomedical Research Imaging Center Marsico Hall (UNC)· Chapel Hill, NCClinical and Translational Research Center (CTRC) Burnett-Womack Building (UNC)· Chapel Hill, NC

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