Study to Evaluate 13 C Isotope Ratio Measurement for Urea Cycle Capacity Assessment
Information source: Cytonet GmbH & Co. KG
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urea Cycle Disorders
Intervention: sodium [1-13C] acetate (Other)
Phase: N/A
Status: Completed
Sponsored by: Cytonet GmbH & Co. KG Official(s) and/or principal investigator(s): Doris Neuenhofer, MD, Principal Investigator, Affiliation: CRS Clinical Research Services Mönchengladbach GmbH
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 Details
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
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Increase of [13C]urea AUC in plasma following oral administration of [13C ]-sodium acetate over baseline
Secondary outcome: Cmax of absolute [13C]urea in plasma
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
CRS Clinical Research Services Mönchengladbach GmbH, Mönchengladbach 41061, Germany
Additional Information
Starting date: September 2009
Last updated: January 14, 2010
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