Tracing Of Real-time glu13Cose Metabolism in Human Immune Cells - Intensive Care Unit

NCT07811180 | Not Yet Recruiting

• 1 other identifier: 260951
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand how cells of the immune system use the common sugar glucose during critical illness. Investigators will intravenously infuse a non-radioactive carbon-13 glucose tracer into adult intensive care unit (ICU) participants over a few hours and collect immune cells from the blood to track uptake and usage of this glucose within these immune cells.

Conditions

Glucose; Metabolism; Isotope Labeling; Immune System and Related Disorders; Critical Illness; Intensive Care Unit (ICU); Sepsis

Keywords

Immunometabolism; Stable Isotope Tracing; Immune Cell Metabolism; Intensive Care Unit; Critical Illness; Critical Care; Metabolism; Glucose; Sepsis; Septic Shock; Acute Respiratory Distress Syndrome; ARDS

Outcome Measures

Primary Outcomes (1)

• 13C6-Glucose Uptake and Metabolism in Immune Cells

  Following 13C6-glucose infusion, peripheral blood immune cell populations will be magnetically isolated from collected blood and analyzed by mass spectrometry to quantify 13C6-glucose and downstream 13C-labeled metabolites.

  Up to 4 hours

Study Arms (1)

13C6-Glucose

OTHER

Participants will receive 10-25 grams of 13C6-glucose intravenously over 2-4 hours during a single ICU study procedure.

Drug: 13C6-Glucose

Interventions

13C6-Glucose DRUG

Compounded as 5% 13C6-glucose in water and given intravenously over 2-4 hours at a total dose of 10-25 grams.

13C6-Glucose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 or older
• Admitted to one of the following VUMC adult ICUs: Medical ICU, Pulmonary ICU
• The participant or legally authorized representative must agree to the genetic analyses required as part of this study

You may not qualify if:

• Pregnant
• Prisoner or in police custody
• Patient desires comfort measures only or has a goals-of-care plan inconsistent with participation in non-beneficial research procedures
• Hemoglobin less than 8 g/dL
• Uncontrolled hyperglycemia (persistent blood glucose \>300 mg/dL) or any clinical condition in which additional IV glucose administration is not appropriate in the opinion of the Study Coordinator, PI, or treating ICU team
• Current participation in another study where the total volume of blood drawn, when added to this study blood draw volume, exceeds 500 mL in an 8-week period
• Unable to safely obtain vascular access required for study infusion and blood collection
• Clinical instability or anticipated clinical care needs that would make the study procedure inappropriate at that time in the opinion of the Study Coordinator, PI, or treating ICU team
• Any medical issue or pharmacologic exposure which, in the opinion of the study investigator, might interfere with the study objectives
• Any reason which, in the opinion of the study investigator, adds additional risk to the patient

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Critical Illness; Sepsis; Shock, Septic; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Matthew T Stier, M.D., Ph.D.

CONTACT

615-875-4978; matthew.stier@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 9, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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 6 years.
• Access Criteria: Data will be made available to researchers who provide a methodologically sound proposal that has been approved by the Principal Investigator and relevant institutional review boards.

Locations

US (1)