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

NCT01002469 — Not applicable, Completed, 10 participants, Cytonet GmbH & Co. KG

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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

Registry	NCT01002469
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	10 (Actual)
Sponsor	Cytonet GmbH & Co. KG (Industry)
Conditions	Urea Cycle Disorders
Interventions	sodium [1-13C] acetate (Other)
Dates	start 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 in Germany

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
sodium [1-13C] acetate	Experimental	Other: sodium [1-13C] acetate

sodium [1-13C] acetate (Other)

+Outcome measures

Primary outcomes

Increase of [13C]urea AUC in plasma following oral administration of [13C ]-sodium acetate over baseline

Secondary outcomes

Cmax of absolute [13C]urea in plasma

+Eligibility

Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers

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 (1)

Facility	City	Country	Status
CRS Clinical Research Services Mönchengladbach GmbH	Mönchengladbach	Germany

+Investigators

Doris Neuenhofer, MD, Principal investigator, CRS Clinical Research Services Mönchengladbach GmbH