NCT01002469

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Cytonet GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Urea Cycle Disorders

Interventions

Type	Name	Description
OTHER	sodium [1-13C] acetate

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-11-01
• Completion: 2009-12-01
• First posted: 2009-10-27
• Last updated: 2010-01-15

Locations

1 site across 1 country: Germany