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RecruitingAccepts healthy volunteersPhase 1/Phase 2

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

University of North Carolina, Chapel Hill · with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NCT04328337

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–45 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1, Phase 2
Target enrollment
40
US sites recruiting
2
Study start
December 8, 2020
Record last updated
March 30, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the 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.

Being studied: Intralipid, 20% Intravenous Emulsion; Placebos

Conditions: Obesity

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Biomedical Research Imaging Center Marsico Hall (UNC)

    Chapel Hill, NC 27514

    Site contact: Joseph Palmiotto · 919-966-9184 · joseph_palmiotto@med.unc.edu

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

    Chapel Hill, NC 27514

    Site contact: Joseph Palmiotto · 919-966-9184 · joseph_palmiotto@med.unc.edu

Study contacts (from the official record)

  • Joseph Palmiotto · 919-966-9184 · joseph_palmiotto@med.unc.edu
All weight loss studies in North Carolina →
Investigating Whether Acute Elevation of Fatty Acid Levels Alters… (NCT04328337) | Bored Studies