Glucose Metabolism Tracer for Metabolism

(TORCH Trial)

Overseen By Jeffrey C Rathmell, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Pregnant, Uncontrolled hyperglycemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Up to 4 hours

12 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It might depend on whether your medications could interfere with the study, so it's best to discuss this with the study investigator.

What data supports the effectiveness of the drug 13C6-Glucose in the clinical trial Glucose Metabolism Tracer for Metabolism?

Research shows that imaging of glucose metabolism, like with FDG-PET, is useful in cancer treatment by helping to monitor how well a treatment is working. This suggests that using glucose-based tracers, such as 13C6-Glucose, could be effective in assessing treatment responses. ^{1 2 3 4 5}

Is 13C6-Glucose safe for use in humans?

Research indicates that 13C-labeled glucose tracers, like 13C6-Glucose, are safe for use in humans as they do not involve radiation and have been used in studies without altering normal glucose or insulin levels. ^{6 7 8 9 10}

How does the drug 13C6-Glucose differ from other treatments for glucose metabolism?

13C6-Glucose is unique because it is a stable isotopic tracer used to study glucose metabolism without the risk of radiation, unlike traditional radioactive tracers. It allows for precise measurement of glucose turnover and recycling in the body, providing detailed insights into metabolic pathways. ^{6 9 11 12 13}

Research Team

Jeffrey C Rathmell, Ph.D.

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This trial is for adults over 18 who want to help understand how immune cells use sugar. It's not for pregnant individuals, prisoners, those in another high-volume blood draw study, or anyone with uncontrolled diabetes or other conditions that could interfere with the study.

Exclusion Criteria

Pregnant

Prisoner or in police custody

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Intravenous infusion of a non-radioactive glucose tracer into participants over a few hours

Up to 4 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• 13C6-Glucose

Trial Overview Researchers are testing how a non-radioactive glucose tracer (13C6-Glucose) is used by immune cells. Participants will receive this tracer intravenously and have their immune cells tracked to see how they process glucose.

Participant Groups

Group I: 13C6-Glucose Experimental Treatment 1 Intervention

10-25gm of 13C6-Glucose

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Findings from Research

The study demonstrated that using 1-[(13)C]glucose with advanced measurement techniques can effectively replace the traditional 6,6-[(2)H(2)]glucose method for assessing glucose metabolism in various populations, including lean and obese individuals, those with impaired glucose tolerance, and diabetes.

This new method allows for a significant reduction in the amount of isotope needed (approximately 15-fold less), making it not only more cost-effective but also improving the accuracy of glucose metabolism measurements by achieving near-physiological conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

13C- and 2H-labelled glucose compared for minimal model estimates of glucose metabolism in man. Bluck, LJ., Clapperton, AT., Coward, WA.[2015]

Using (13)C metabolic flux analysis, researchers identified that [1,2-(13)C(2)]glucose is the most effective tracer for accurately estimating metabolic fluxes in cancer cell metabolism, particularly for glycolysis and the pentose phosphate pathway.

The study also found that [U-(13)C(5)]glutamine is the best tracer for analyzing the tricarboxylic acid (TCA) cycle, providing essential insights for designing more effective metabolic flux analysis experiments in mammalian cells.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of 13C isotopic tracers for metabolic flux analysis in mammalian cells. Metallo, CM., Walther, JL., Stephanopoulos, G.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Lactate Lights up PI3K Inhibitor Resistance in Breast Cancer. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Functional PET imaging in cancer drug development. [2016]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Cancer drug development using glucose metabolism radiopharmaceuticals. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Metabolic design of combination therapy: use of enhanced fluorodeoxyglucose uptake caused by chemotherapy. [2016]

5. Japan pubmed.ncbi.nlm.nih.gov

[Perspective for imaging of tumor metabolism]. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Comparison of [3,4-13C2]glucose to [6,6-2H2]glucose as a tracer for glucose turnover by nuclear magnetic resonance. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

[123I]-6-deoxy-6-iodo-D-glucose (6DIG): a potential tracer of glucose transport. [2019]

8. England pubmed.ncbi.nlm.nih.gov

13C- and 2H-labelled glucose compared for minimal model estimates of glucose metabolism in man. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Estimation of glucose turnover with stable tracer glucose-1-13C. [2013]

10. England pubmed.ncbi.nlm.nih.gov

Assessment of glucose turnover in normal man with the use of a non-radioactive isotopically labelled preparation, [6,6-2H]glucose, as tracer. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Stable isotopic tracers for studies of glucose metabolism. [2013]

12. United States pubmed.ncbi.nlm.nih.gov

Glucose isotope, carbon recycling, and gluconeogenesis using [U-13C]glucose and mass isotopomer analysis. [2019]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of 13C isotopic tracers for metabolic flux analysis in mammalian cells. [2021]