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

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ClinicalTrials.gov Identifier: NCT01002469
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : January 15, 2010
Information provided by:
Cytonet GmbH & Co. KG

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.

Condition or disease Intervention/treatment
Urea Cycle Disorders Other: sodium [1-13C] acetate

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : September 2009
Primary Completion Date : November 2009
Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: sodium [1-13C] acetate Other: sodium [1-13C] acetate

Primary Outcome Measures :
  1. Increase of [13C]urea AUC in plasma following oral administration of [13C ]-sodium acetate over baseline

Secondary Outcome Measures :
  1. Cmax of absolute [13C]urea in plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002469

CRS Clinical Research Services Mönchengladbach GmbH
Mönchengladbach, Germany, 41061
Sponsors and Collaborators
Cytonet GmbH & Co. KG
Principal Investigator: Doris Neuenhofer, MD CRS Clinical Research Services Mönchengladbach GmbH

Responsible Party: Heinz Kriegbaum, Cytonet GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT01002469     History of Changes
Other Study ID Numbers: CCD07
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: January 15, 2010
Last Verified: January 2010

Keywords provided by Cytonet GmbH & Co. KG:
isotope ratio measurement
urea cycle
13C acetate
Healthy adults

Additional relevant MeSH terms:
Urea Cycle Disorders, Inborn
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases