In Vivo Assessment of Glutamine Utilization by Bone Marrow Plasma Cells

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03384108
• Other study ID #: 16-008291
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: January 2026

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Wilson Gonsalves
• Phone: 5072842511
• Email: gonsalves.wilson[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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