ObesityPhase 1/2NCT04328337
Investigating Whether Acute Elevation of Fatty Acid Levels Alters Cerebral Glucose Transport and Metabolism
A Phase 1/2 study testing Intralipid, 20% Intravenous Emulsion in people with Obesity, run by University of North Carolina, Chapel Hill at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Intralipid, 20% Intravenous Emulsion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Dec 2020to 1 Jun 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-45 years
- HbA1C <6.5%
- Normal weight individuals: BMI 17-25 kg/m^2
- Obese individuals: BMI >30 kg/m^2
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Biomedical Research Imaging Center Marsico Hall (UNC)
Chapel Hill, North Carolina, 27514
Clinical and Translational Research Center (CTRC) Burnett-Womack Building (UNC)
Chapel Hill, North Carolina, 27514
About this study
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.
Read the 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).
- Conditions
- Obesity
- Being tested
- Intralipid, 20% Intravenous Emulsion, Placebos
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralipid, 20% Intravenous EmulsionDrug
Infusion of Intralipid 20%
PlacebosDrug
saline 30 ml/hr for 12 hours through an IV
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain glucose transport capacity
Measurement of brain glucose transport rates using magnetic resonance spectroscopy (MRS).
Measured: Through End of Study (Up to 12 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start8 Dec 2020
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janice Jin Hwang, MD, MHS, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328337
- Sponsor's protocol ID
- 22-2455
- Other IDs
- 1R01DK123227-01
- Status last verified
- Oct 2026
- First submitted
- 27 Mar 2020
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Whether Acute Elevation of Fatty Acid Levels Alters Cerebral Glucose Transport and Metabolism
- ClinicalTrials.gov ID
- NCT04328337
- Acronym / sponsor ID
- 22-2455
- Conditions
- Obesity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-diabetic, normal weight individuals receiving Intralipid | Experimental | Drug: Intralipid, 20% Intravenous EmulsionNon-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) |
| Non-diabetic, normal weight individuals receiving saline | Placebo comparator | Drug: PlacebosNon-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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-45 years
- HbA1C <6.5%
- Normal weight individuals: BMI 17-25 kg/m^2
- Obese individuals: BMI >30 kg/m^2
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intralipid, 20% Intravenous EmulsionInfusion of Intralipid 20% | Drug | Non-diabetic, normal weight individuals receiving Intralipid |
| Placebossaline 30 ml/hr for 12 hours through an IV | Drug | Non-diabetic, normal weight individuals receiving saline |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice Jin Hwang, MD, MHS principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intralipid, 20% Intravenous Emulsion in people with Obesity, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brain glucose transport capacity (time frame: Through End of Study (Up to 12 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.