Investigating Whether Acute Elevation of Fatty Acid Level... | NCT04328337

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

NCT04328337

Sponsor

University of North Carolina, Chapel Hill

Status

Recruiting

Last Update Posted

Mar 30, 2025Actual

Enrollment

40Estimated

Phase

Phase 1Phase 2

Conditions

Obesity

Interventions

Intralipid, 20% Intravenous Emulsion
Placebos

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R01DK123227-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 8, 2020Actual

Primary Completion Date

Jun 1, 2026Estimated

Completion Date

Jun 1, 2026Estimated

First Submitted Date

Mar 27, 2020

First Submission Date that Met QC Criteria

Mar 27, 2020

First Posted Date

Mar 31, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2025

Last Update Posted Date

Mar 30, 2025Actual

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Intralipid, 20% Intravenous Emulsion	Drug	Infusion of Intralipid 20%	Non-diabetic, normal weight individuals receiving Intralipid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Joseph Palmiotto	Contact	919-966-9184		joseph_palmiotto@med.unc.edu

Overall Officials

Name	Affiliation	Role
Janice Jin Hwang, MD, MHS	University of North Carolina, Chapel Hill	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Biomedical Research Imaging Center Marsico Hall (UNC)	Recruiting	Chapel Hill	North Carolina	27514	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C545823	soybean oil, phospholipid emulsion

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided