Viewing Study NCT01912235


Ignite Creation Date: 2025-12-24 @ 10:29 PM
Ignite Modification Date: 2025-12-30 @ 11:24 PM
Study NCT ID: NCT01912235
Status: COMPLETED
Last Update Posted: 2018-01-09
First Post: 2013-07-26
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Arginine Synthesis in Healthy Adult Humans
Sponsor: The Hospital for Sick Children
Organization:

Study Overview

Official Title: Arginine Synthesis in Healthy Adult Humans: Does Proline or Glutamate Provide the 5-Carbon Chain?
Status: COMPLETED
Status Verified Date: 2018-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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.
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: