Urea Cycle Disorders
Conditions
Keywords
isotope ratio measurement, urea cycle, 13C acetate, Healthy adults
Brief 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.
Interventions
OTHERsodium [1-13C] acetate
Sponsors
Cytonet GmbH & Co. KG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Group 1 + 2: Healthy subjects * Group 3: Healthy asymptomatic subjects genetically disposed to urea cycle disorders * All: age 18 to 50 years (adult) * Written informed consent
Exclusion criteria
* Presence of acute infection * Participation in other clinical trials within 30 days prior to inclusion * Severe coagulopathy * Severe systemic or chronic disease * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase of [13C]urea AUC in plasma following oral administration of [13C ]-sodium acetate over baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax of absolute [13C]urea in plasma | — |
Countries
Germany
Outcome results
None listed