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

This study has been completed.
Sponsor:
Information provided by:
Cytonet GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT01002469
First received: October 26, 2009
Last updated: January 14, 2010
Last verified: January 2010
History of Changes
  Purpose

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 Intervention
Urea Cycle Disorders
 Other: sodium [1-13C] acetate

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cytonet GmbH & Co. KG:

Primary Outcome Measures:
  • Increase of [13C]urea AUC in plasma following oral administration of [13C ]-sodium acetate over baseline [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax of absolute [13C]urea in plasma [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sodium [1-13C] acetate Other: sodium [1-13C] acetate

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002469

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

No publications provided

Responsible Party: Heinz Kriegbaum, Cytonet GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT01002469     History of Changes
Other Study ID Numbers: CCD07
Study First Received: October 26, 2009
Last Updated: January 14, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on June 18, 2013