Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 45Years
All Genders
Healthy Volunteers
NCT04328337

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

Led by University of North Carolina, Chapel Hill · Updated on 2025-03-30

40

Participants Needed

2

Research Sites

285 weeks

Total Duration

On this page

Sponsors

U

University of North Carolina, Chapel Hill

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-45 years
  • HbA1C <6.5%
  • Normal weight individuals: BMI 17-25 kg/m^2
  • Obese individuals: BMI >30 kg/m^2
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Biomedical Research Imaging Center Marsico Hall (UNC)

Chapel Hill, North Carolina, United States, 27514

Actively Recruiting

2

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

Chapel Hill, North Carolina, United States, 27514

Actively Recruiting

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Research Team

J

Joseph Palmiotto

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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