Arginine Synthesis in Healthy Adult Humans

January 5, 2018 updated by: Dr. Paul Pencharz, The Hospital for Sick Children

Arginine Synthesis in Healthy Adult Humans: Does Proline or Glutamate Provide the 5-Carbon Chain?

Arginine synthesis in mammals is a complex process involving at least 8 enzymes and intracellular and interorgan transfer of substrates.

The investigators have shown in our neonatal studies that there is no conversion of glutamate to arginine but proline label appears in ornithine, citrulline and arginine. It is clear therefore that arginine is synthesized in human neonates from proline.

In adults the source of the carbon backbone is less clear.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Through a series of test in healthy adults using tandem mass spectrometry with carbon labeled GLN and nitrogen labeled PRO to determine the dietary source for the carbon chain of ORN, CIT and ARG. Additionally, using Nitrogen labeled GLN, we will identify the source of the nitrogen atoms in these amino acids.

Using guanidino - 15N2 arginine, 1-13C Glutamine, 2-15N Glutamine and 15N Proline we will be able to:

  1. determine the flux of arginine and proline in healthy adult volunteers
  2. determine and compare the flux of carbon and nitrogen labeled glutamine
  3. demonstrate whether glutamine or proline provides the carbon backbone for ornithine, citrulline and arginine in adults.
  4. the source of the N atoms in ornithine, citrulline and arginine.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 5 men of average weight 80 kg will be studied
  • healthy, with no know disease of liver, and/or kidney
  • weight stable

Exclusion Criteria:

  • weith loss or gain over the last three months
  • on medications known to affect amino acid metabolism
  • known liver, kidney disease condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Test Study 1: 2-15N glutamine
To determine the contributions make by glutamine to the provision of nitrogen for ornithine, citrulline and arginine syntesis in adults.
Other: 2-15N glutamine
Glutamine with N15 isotope tracer
Active Comparator: Test Study 2: 15N2 arginine &15N proline
administration of 15N2 arginine &15N proline to measure arginine and proline flux
Other: 15N2 arginine and 15N proline
Arginine and Proline isotope tracers
Active Comparator: Study Test 3: 1-13C glutamine
to determine to contribution of glutamine to the carbon skeleton of ornithine, citrulline and arginine in adults.
Other: 1-13C glutamine
Glutamine carbon isotope tracer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood Isotope Levels
Time Frame: 8 hours
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

July 26, 2013

First Submitted That Met QC Criteria

July 30, 2013

First Posted (Estimate)

July 31, 2013

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 5, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 02/02/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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