Ureagenesis Analysis in Healthy Subjects and in Urea Cycle Disorder Patients
NCT ID: NCT05671666
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2019-10-31
2035-12-31
Brief Summary
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The measurement of ureagenesis is a tool to analyze the entire function of the urea cycle in a single test. This is more meaningful for the characterization of UCD patients than the analysis of single metabolites or enzymes. Therefore, the test will be important to evaluate current and future novel therapies.
The term "ureagenesis" means "production of urea", which is the main task of the urea cycle. This total urea production can be measured with a "tracer" (in this case a stable ammonium chloride isotope). This tracer is non-radioactive and non-toxic. It is for example used as an unmarked substance in cough syrup, diuretic drugs and as food additive. Thus, the tracer does not pose a risk to the participant, especially since only a very low dose is applied.
The investigators will analyze specific substances from the urea cycle (namely \[15N, 14N\] urea and several \[15N\] amino acids) that are produced during the test and compare them with results from healthy people. Venous and capillary blood will be sampled at 15 to 30 minutes intervals up to 2 hours after administration of the stable isotope tracer. The maximum test duration is 5 hours.
This project is being carried out at one site, namely the University Children's Hospital in Zurich.
This project is being carried out under Swiss law. The responsible Ethics Committee has reviewed and approved the study.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Healthy controls or UCD patients
Urea cycle flux study
Quantification of ureagenesis
Interventions
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Urea cycle flux study
Quantification of ureagenesis
Eligibility Criteria
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Inclusion Criteria
* subjects with a UCD confirmed by genetic or enzymatic diagnostics at any age and given written informed consent
Exclusion Criteria
* pregnant or lactating women.
* UCD patients with acute and chronic (other than her/his UCD) disease requiring treatment
* UCD patients in which intake of carglumic acid cannot be stopped for 24 hours prior to the test
ALL
Yes
Sponsors
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University Children's Hospital, Zurich
OTHER
Responsible Party
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Locations
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University Children's Hospital
Zurich, Canton of Zurich, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Ureagenesis01352
Identifier Type: -
Identifier Source: org_study_id
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