Status:
RECRUITING
Investigating Whether Acute Elevation of Fatty Acid Levels Alters Cerebral Glucose Transport and Metabolism
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
PHASE2
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 gluco...
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 ...
Eligibility Criteria
Inclusion
- Age 18-45 years
- HbA1C \<6.5%
- Normal weight individuals: BMI 17-25 kg/m\^2
- Obese individuals: BMI \>30 kg/m\^2
Exclusion
- 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
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04328337
Start Date
December 8 2020
End Date
June 1 2026
Last Update
March 30 2025
Active Locations (2)
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1
Biomedical Research Imaging Center Marsico Hall (UNC)
Chapel Hill, North Carolina, United States, 27514
2
Clinical and Translational Research Center (CTRC) Burnett-Womack Building (UNC)
Chapel Hill, North Carolina, United States, 27514