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Study to Evaluate 13 C Isotope Ratio Measurement for Urea Cycle Capacity Assessment

Urea Cycle Disorders Clinical Trial

Official title:
Pilot Feasibility Study in Healthy Subjects and Healthy Asymptomatic Subjects Genetically Disposed to Urea Cycle Disorders to Evaluate the Use of 13 C Isotope Ratio Measurement

Clinical Trial Summary

In this short-term study a method for the evaluation of the metabolic competency of the urea cycle in vivo will be assessed. In order to monitor the efficacy of new treatment options for patients with urea cycle disorders and to monitor the severity of the disease, a reliable and safe quantitative method for the measurement of the urea cycle flux is required.

Urea synthesis will be evaluated by administering sodium [1-13C]-acetate and measuring subsequent incorporation of [13C] label from Na-acetate into urea in healthy volunteers and asymptomatic subjects genetically disposed to urea cycle disorders.

Clinical Trial Description

n/a

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01002469
Study type Interventional
Source Cytonet GmbH & Co. KG
Contact
Status Completed
Phase N/A
Start date September 2009
Completion date December 2009
View Details
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