In Vivo Assessment of Glutamine Utilization by Bone Marrow Plasma Cells

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2025

Detailed Description

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.

Interventions

  • Other: 5-13C-Glutamine
    • Intravenous infusion of 5-13C-Glutamine
  • Other: Bone marrow aspiration
    • Bone marrow aspiration of bone marrow aspirate

Arms, Groups and Cohorts

  • Experimental: In Vivo
    • Infusion of 5-13C-Glutamine intravenously in healthy subjects prior to undergoing a bone marrow aspiration.
  • Placebo Comparator: Ex Vivo
    • Healthy subjects will undergoing a bone marrow aspiration and then the plasma cells acquired will be cultured ex vivo in cell culture media containing 5-13C-Glutamine.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Provider of Information About this Clinical Study
    • Principal Investigator: Wilson I. Gonsalves, M.D., Senior Associate Consultant – Mayo Clinic
  • Overall Official(s)
    • Wilson Gonsalves, MD, Principal Investigator, Mayo Clinic
  • Overall Contact(s)
    • Wilson Gonsalves, 5072842511, gonsalves.wilson@mayo.edu

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