Recruiting
Phase 1
Phase 2

Fatty Acids

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT04328337

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Intralipid, 20% Intravenous Emulsion

Placebos

Study Details

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.

Conditions

Obesity

Study ID

NCT04328337

Start date

Dec 8, 2020

Status verified date

Mar, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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

Interventions

Intralipid, 20% Intravenous Emulsion

Infusion of Intralipid 20%

Placebos

saline 30 ml/hr for 12 hours through an IV

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Joseph Palmiotto

919-966-9184joseph_palmiotto@med.unc.edu

Locations

Biomedical Research Imaging Center Marsico Hall (UNC)

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Joseph Palmiotto

919-966-9184joseph_palmiotto@med.unc.edu

Clinical and Translational Research Center (CTRC) Burnett-Womack Building (UNC)

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Joseph Palmiotto

919-966-9184joseph_palmiotto@med.unc.edu

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Mar 30, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2025-03-30.