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

NCT01002469 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2010-01-15

No results posted yet for this study

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.

Conditions

  • Urea Cycle Disorders

Interventions

OTHER

sodium [1-13C] acetate

Sponsors & Collaborators

  • Cytonet GmbH & Co. KG

    lead INDUSTRY

Principal Investigators

  • Doris Neuenhofer, MD · CRS Clinical Research Services Mönchengladbach GmbH

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2009-11-30
Completion
2009-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01002469 on ClinicalTrials.gov