In Vivo Assessment of Glutamine Utilization by Bone Marrow Plasma Cells

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2026-01-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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In Vivo

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

Group Type EXPERIMENTAL

5-13C-Glutamine

Intervention Type OTHER

Intravenous infusion of 5-13C-Glutamine

Bone marrow aspiration

Intervention Type OTHER

Bone marrow aspiration of bone marrow aspirate

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.

Group Type PLACEBO_COMPARATOR

Bone marrow aspiration

Intervention Type OTHER

Bone marrow aspiration of bone marrow aspirate

Interventions

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5-13C-Glutamine

Intravenous infusion of 5-13C-Glutamine

Intervention Type OTHER

Bone marrow aspiration

Bone marrow aspiration of bone marrow aspirate

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes