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Glutamine Metabolism Assessment in Healthy Subjects

N/A

Recruiting

Led By Wilson Gonsalves, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 18-60

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 hour

Awards & highlights

Study Summary

This trial will compare the effectiveness of two methods of measuring how well glutamine is used by plasma cells in the bone marrow.

Who is the study for?

This trial is for healthy adults aged 18-60 who can give written consent. It's not suitable for pregnant individuals, those with liver disease, kidney failure, anemia (low hemoglobin levels), heavy alcohol users (>2 drinks per day), people with a BMI over 30, or anyone currently using steroids.Check my eligibility

What is being tested?

The study is testing how bone marrow plasma cells in healthy subjects use glutamine. Participants will undergo a bone marrow aspiration and receive a special form of glutamine labeled with carbon-13 to track its utilization in the body compared to lab-based tests.See study design

What are the potential side effects?

Potential side effects may include discomfort at the aspiration site, bruising, bleeding or infection risks from the procedure. The infused labeled glutamine is expected to have minimal side effects as it's similar to naturally occurring amino acids.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 60 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 hour

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 hour

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 hour for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of enrichment of 13-Carbon molecules in the TCA cycle metabolites of plasma cells measured by gas chromatography mass spectrometry.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: In VivoExperimental Treatment2 Interventions

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

Group II: Ex VivoPlacebo Group1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,212 Previous Clinical Trials

3,767,018 Total Patients Enrolled

Wilson Gonsalves, MDPrincipal InvestigatorMayo Clinic

Media Library

5-13C-Glutamine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03384108 — N/A

Healthy Subjects Research Study Groups: Ex Vivo, In Vivo

Healthy Subjects Clinical Trial 2023: 5-13C-Glutamine Highlights & Side Effects. Trial Name: NCT03384108 — N/A

5-13C-Glutamine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03384108 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this experimental study still accessible to applicants?

"Affirmative. The information hosted on clinicaltrials.gov attests to the current recruitment status of this medical study, which was first announced September 1st 2017 and most recently updated February 10th 2022. 20 individuals are needed for research at a single trial site."

Answered by AI

Is the age restriction for participation in this experiment limited to those over 70?

"This trial is open to patients aged between 18 and 60. In addition, 50 studies are for minors under the age of consent while another 370 trials cater specifically towards those over 65 years old."

Answered by AI

How many participants are taking part in this clinical experiment?

"Indeed, the clinicaltrial.gov portal shows that this medical trial is open for enrollment and has been actively updated since its initial posting on September 1st 2017. The ongoing research requires 20 subjects at a single site to complete their study."

Answered by AI

Is my involvement in this trial permissible?

"To meet the criteria for this research, volunteers must have healthy subjects and be between 18-60 years old. There are 20 positions available in total."

Answered by AI

Recent research and studies

Cancer & MetabolismJournal

In Vivo Assessment of Glutamine Anaplerosis into the TCA Cycle in Human Pre-malignant and Malignant Clonal Plasma Cells

Gonsalves, Wilson I., Jin Sung Jang, Erik Jessen, Taro Hitosugi, Laura A. Evans, Dragan Jevremovic, Xuan-Mai Pettersson, et al.. 2020. “In Vivo Assessment of Glutamine Anaplerosis into the TCA Cycle in Human Pre-malignant and Malignant Clonal Plasma Cells”. Cancer & Metabolism. Springer Science and Business Media LLC. doi:10.1186/s40170-020-00235-4.

clinicaltrials.govStudy

In Vivo Assessment of Glutamine Utilization by Bone Marrow Plasma Cells

Wilson I. Gonsalves, M.D. 2017. "In Vivo Assessment of Glutamine Utilization by Bone Marrow Plasma Cells". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03384108.