In Vivo Assessment of Glutamine Utilization by Bone Marrow Plasma Cells

NCT03384108 | Recruiting DMC

• 1 other identifier: 16-008291
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

In Vivo

EXPERIMENTAL

Infusion of 5-13C-Glutamine intravenously in healthy subjects prior to undergoing a bone marrow aspiration.

Other: 5-13C-Glutamine; Other: Bone marrow aspiration

Ex Vivo

PLACEBO COMPARATOR

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

Interventions

5-13C-Glutamine OTHER

Intravenous infusion of 5-13C-Glutamine

In Vivo

Bone marrow aspiration OTHER

Bone marrow aspiration of bone marrow aspirate

Ex Vivo; In Vivo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18-60
• Able to provide written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 33308307 DERIVED

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Wilson Gonsalves, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wilson Gonsalves

CONTACT

5072842511; gonsalves.wilson@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate Consultant

Model Details: In Vivo vs. Ex Vivo assessment of 5-13C-Glutamine incorporation by plasma cells via a bone marrow aspiration.

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: December 27, 2017
• Study Start: September 1, 2017
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)