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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04328337
• Other study ID #: 22-2455
• Secondary ID: 1R01DK123227-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 8, 2020
• Est. completion date: June 1, 2025

Study information

• Verified date: October 2023
• Source: University of North Carolina, Chapel Hill
• Contact: Joseph Palmiotto
• Phone: 919-966-9184
• Email: joseph_palmiotto[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Intralipid, 20% Intravenous Emulsion
Infusion of Intralipid 20%
• Placebos
saline 30 ml/hr for 12 hours through an IV

Locations

Country	Name	City	State
United States	Biomedical Research Imaging Center Marsico Hall (UNC)	Chapel Hill	North Carolina
United States	Clinical and Translational Research Center (CTRC) Burnett-Womack Building (UNC)	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)