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

January 14, 2010 updated by: Cytonet GmbH & Co. KG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mönchengladbach, Germany, 41061
        • CRS Clinical Research Services Mönchengladbach GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sodium [1-13C] acetate
Other: sodium [1-13C] acetate

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Cmax of absolute [13C]urea in plasma

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cytonet GmbH & Co. KG

Investigators

  • Principal Investigator: Doris Neuenhofer, MD, CRS Clinical Research Services Mönchengladbach GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

October 26, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (Estimate)

October 27, 2009

Study Record Updates

Last Update Posted (Estimate)

January 15, 2010

Last Update Submitted That Met QC Criteria

January 14, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCD07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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