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

NCT04328337 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 22-24551R01DK123227-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Change in brain glucose transport capacity

  Measurement of brain glucose transport rates using magnetic resonance spectroscopy (MRS).

  Through End of Study (Up to 12 hours)

Study Arms (2)

Non-diabetic, normal weight individuals receiving Intralipid

EXPERIMENTAL

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)

Drug: Intralipid, 20% Intravenous Emulsion

Non-diabetic, normal weight individuals receiving saline

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

Intralipid, 20% Intravenous Emulsion DRUG

Infusion of Intralipid 20%

Non-diabetic, normal weight individuals receiving Intralipid

Placebos DRUG

saline 30 ml/hr for 12 hours through an IV

Non-diabetic, normal weight individuals receiving saline

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45 years
• HbA1C \<6.5%
• Normal weight individuals: BMI 17-25 kg/m\^2
• Obese individuals: BMI \>30 kg/m\^2

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Biomedical Research Imaging Center Marsico Hall (UNC)

Chapel Hill, North Carolina, 27514, United States

RECRUITING

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

Chapel Hill, North Carolina, 27514, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

soybean oil, phospholipid emulsion

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Janice Jin Hwang, MD, MHS

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Palmiotto

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: March 31, 2020
• Study Start: December 8, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)