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
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.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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