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

Tracking Information

First Received Date ^ICMJE

October 26, 2009

Last Updated Date

January 14, 2010

Start Date ^ICMJE

September 2009

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01002469 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Urea Cycle Disorders

Intervention ^ICMJE

Other: sodium [1-13C] acetate

Study Arm (s)

Experimental: sodium [1-13C] acetate

Intervention: Other: sodium [1-13C] acetate

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2009

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01002469

Other Study ID Numbers ^ICMJE

CCD07

Has Data Monitoring Committee

Responsible Party

Heinz Kriegbaum, Cytonet GmbH & Co. KG

Study Sponsor ^ICMJE

Cytonet GmbH & Co. KG

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Doris Neuenhofer, MD

CRS Clinical Research Services Mönchengladbach GmbH

Information Provided By

Cytonet GmbH & Co. KG

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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