In Vivo Assessment of Glutamine Utilization by Bone Marrow Plasma Cells

Mayo Clinic

Status: Enrolling

Conditions: Healthy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03384108

16-008291

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups, including a placebo group

In Vivo

Experimental group

Description:

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

Treatment:

Other: 5-13C-Glutamine

Other: Bone marrow aspiration

Ex Vivo

Placebo Comparator group

Description:

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.

Treatment:

Other: Bone marrow aspiration