Tracing Of Real-time glu13Cose Metabolism in Human Immune... | NCT06930976

Studies
Tracing Of Real-time glu13Cose Metabolism in Human Immune Cells

NCT06930976

Sponsor

Vanderbilt University Medical Center

Status

Recruiting

Last Update Posted

Nov 4, 2025Actual

Enrollment

12Estimated

Phase

Not Applicable

Conditions

Glucose
Metabolism
Isotope Labeling
Immune System and Related Disorders

Interventions

13C6-Glucose

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

Status Module

Record Verification Date

Oct 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

Oct 1, 2025Actual

Primary Completion Date

Jun 30, 2027Estimated

Completion Date

Jun 30, 2027Estimated

First Submitted Date

Apr 8, 2025

First Submission Date that Met QC Criteria

Apr 8, 2025

First Posted Date

Apr 16, 2025Actual

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

Nov 1, 2025

Last Update Posted Date

Nov 4, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Matthew Stier, Assistant Professor of Medicine, Vanderbilt University Medical CenterPrincipal Investigator

Lead Sponsor

Vanderbilt University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to understand how cells of the immune system use the common sugar glucose to fuel energy production and as a building block within the cell. Investigators will intravenously infuse a non-radioactive glucose tracer into participants over a few hours and collect immune cells from the blood to track uptake and usage of this glucose within these immune cells.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
13C6-Glucose	Other	10-25gm of 13C6-Glucose	Drug: 13C6-Glucose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
13C6-Glucose	Drug	Compounded as 5% 13C6-Glucose in sterile water given IV over 2-4 hours as a split bolus and infusion	13C6-Glucose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
13C6-glucose uptake in immune cells	Detection of 13C6-glucose-derived metabolites in neutrophils, monocytes, CD4 T cells, and CD8 T cells using gas and liquid chromatography-mass spectrometry (GC-MS and LC-MS) following magnetic enrichment of these immune cell subsets.	Up to 4 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults aged 18 or older

Exclusion Criteria:

Pregnant
Prisoner or in police custody
Uncontrolled hyperglycemia/diabetes
Current participation in another study where the total volume of blood drawn, when added to this study blood draw volume, exceeds 500cc in an 8 week period
Any medical issue or pharmacologic exposure which, in the opinion of the study investigator, that might interfere with the study objectives
Any reason which, in the opinion of the study investigator, adds additional risk to the participant

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Matthew T Stier, M.D., Ph.D.	Contact	615-875-4978		matthew.stier@vumc.org

Overall Officials

Name	Affiliation	Role
Matthew T Stier, M.D., Ph.D.	Vanderbilt University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University Medical Center	Recruiting	Nashville	Tennessee	37212	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Individual participant data that underlie the results reported will be made available after de-identification.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code

Time Frame

The data will become available within 6 months of publication of the outcomes and will remain available for at least 5 years.

Access Criteria

Data will be made available to researchers who provide a methodologically sound proposal that has been approved by the Principle Investigator and relevant institutional review boards.

URL

Not provided