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NCT Number: NCT03384108

In Vivo Assessment of Glutamine Utilization by Bone Marrow Plasma Cells

This pilot study will first establish the feasibility of an in vivo methodology of assessing the utilization of glutamine into the TCA cycle of normal bone marrow plasma cells from healthy subjects while comparing it to an ex vivo approach

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Wilson Gonsalves, MD

CONTACT

[email protected]

5072842511

About this study

Twenty healthy adult study participants between the ages of 18 and 60 years will be recruited to participate in this pilot study that will include two groups: a) Ex Vivo group (10 volunteers) and b) In Vivo group (10 volunteers). Volunteers will be recruited to either group in a sequential alternating fashion.

In vivo 13C SIRM studies evaluating the utilization of glutamine into the TCA cycle of normal bone marrow plasma cells.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 18-60
  • Able to provide written consent

Exclusion criteria

  • Renal Failure
  • Pregnancy
  • Active steroid use
  • Active liver Disease
  • Anemia (Hemoglobin < 12.5 g/dL in men and < 11.5 g/dL in women)
  • H/O alcohol use (average > 2 drinks per day)
  • BMI > 30

Treatment and study plan

5-13C-Glutamine

Other

Intravenous infusion of 5-13C-Glutamine

Bone Marrow aspiration

Other

Bone marrow aspiration of bone marrow aspirate

Primary outcomes

  1. Percentage of enrichment of 13-Carbon molecules in the TCA cycle metabolites of plasma cells measured by gas chromatography mass spectrometry.

    Time frame: Through study completion, an average of 1 hour

    The plasma cells obtained from the bone marrow aspiration will be processed to determine the percent of 13-carbon enrichment in the various molecules of the TCA cycle within the plasma cells. The outcomes will be reported as a percentage. E.G. 5% of glutamine is labeled with 13-Carbon; e.g. 4% of glutamate is labeled with 13-carbon etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Wilson Gonsalves

CONTACT

[email protected]

5072842511

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

In Vivo Assessment of Glutamine Utilization by Bone Marrow Plasma Cells in Healthy Subjects Using Stable Isotope Resolved Metabolomics: A Pilot Study

Important dates

Study start
2017
Primary completion
2028
Study completion
2028
First posted
Dec 27, 2017
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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