In Vivo Assessment of Glutamine Utilization by Bone Marrow Plasma Cells
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 5-13C-Glutamine, Bone marrow aspiration.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
In Vivo Assessment of Glutamine Utilization by Bone Marrow Plasma Cells in Healthy Subjects Using Stable Isotope Resolved Metabolomics: A Pilot Study
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
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
Primary outcome 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Mayo Clinic — Rochester
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. PMID 33308307
Identifiers
NCT: NCT03384108 · 16-008291