- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04328337
Investigating Whether Acute Elevation of Fatty Acid Levels Alters Cerebral Glucose Transport and Metabolism
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Joseph Palmiotto
- Phone Number: 919-966-9184
- Email: joseph_palmiotto@med.unc.edu
Study Contact Backup
- Name: Cassandra Donahue, RDN, LDN, CDCES
- Phone Number: 984-974-3001
- Email: cassandra_donahue@med.unc.edu
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- Recruiting
- Biomedical Research Imaging Center Marsico Hall (UNC)
-
Contact:
- Joseph Palmiotto
- Phone Number: 919-966-9184
- Email: joseph_palmiotto@med.unc.edu
-
Contact:
- Cassandra Donahue, RDN, LDN, CDCES
- Phone Number: 984-974-3001
- Email: cassandra_donahue@med.unc.edu
-
Chapel Hill, North Carolina, United States, 27514
- Recruiting
- Clinical and Translational Research Center (CTRC) Burnett-Womack Building (UNC)
-
Contact:
- Joseph Palmiotto
- Phone Number: 919-966-9184
- Email: joseph_palmiotto@med.unc.edu
-
Contact:
- Cassandra Donahue, RDN, LDN, CDCES
- Phone Number: 984-974-3001
- Email: cassandra_donahue@med.unc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Investigators
- Principal Investigator: Janice Jin Hwang, MD, MHS, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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