In Vivo Assessment of Glutamine Utilization by Bone Marrow Plasma Cells

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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: 5-13C-Glutamine; Other: Bone marrow aspiration

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wilson Gonsalves; Phone Number: 5072842511; Email: gonsalves.wilson@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Wilson Gonsalves, MD; Phone Number: 507-284-2511; Email: gonsalves.wilson@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: In Vivo; Infusion of 5-13C-Glutamine intravenously in healthy subjects prior to undergoing a bone marrow aspiration.	Other: 5-13C-Glutamine; Intravenous infusion of 5-13C-Glutamine; Other: Bone marrow aspiration; Bone marrow aspiration of bone marrow aspirate
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.	Other: Bone marrow aspiration; Bone marrow aspiration of bone marrow aspirate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of enrichment of 13-Carbon molecules in the TCA cycle metabolites of plasma cells measured by gas chromatography mass spectrometry.	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.	Through study completion, an average of 1 hour

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Wilson Gonsalves, MD, Mayo Clinic

Publications and helpful links

General Publications

• Gonsalves WI, Jang JS, Jessen E, Hitosugi T, Evans LA, Jevremovic D, Pettersson XM, Bush AG, Gransee J, Anderson EI, Kumar SK, Nair KS. In vivo assessment of glutamine anaplerosis into the TCA cycle in human pre-malignant and malignant clonal plasma cells. Cancer Metab. 2020 Dec 11;8(1):29. doi: 10.1186/s40170-020-00235-4.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: November 3, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (Actual): December 27, 2017

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 6, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 16-008291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No