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

February 5, 2024 updated by: University of North Carolina, Chapel Hill
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.

Study Overview

Status

Recruiting

Conditions

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).

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • Clinical and Translational Research Center (CTRC) Burnett-Womack Building (UNC)
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Infusion of Intralipid 20%
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
saline 30 ml/hr for 12 hours through an IV

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Janice Jin Hwang, MD, MHS, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2020

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

March 27, 2020

First Submitted That Met QC Criteria

March 27, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 22-2455
  • 1R01DK123227-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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