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

Primary Purpose

Urea Cycle Disorders

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
sodium [1-13C] acetate
Sponsored by
Cytonet GmbH & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Urea Cycle Disorders focused on measuring isotope ratio measurement, urea cycle, 13C acetate, Healthy adults

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CRS Clinical Research Services Mönchengladbach GmbH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sodium [1-13C] acetate

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cmax of absolute [13C]urea in plasma

Full Information

First Posted
October 26, 2009
Last Updated
January 14, 2010
Sponsor
Cytonet GmbH & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT01002469
Brief Title
Study to Evaluate 13 C Isotope Ratio Measurement for Urea Cycle Capacity Assessment
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 Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cytonet GmbH & Co. KG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urea Cycle Disorders
Keywords
isotope ratio measurement, urea cycle, 13C acetate, Healthy adults

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sodium [1-13C] acetate
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
sodium [1-13C] acetate
Primary Outcome Measure Information:
Title
Increase of [13C]urea AUC in plasma following oral administration of [13C ]-sodium acetate over baseline
Secondary Outcome Measure Information:
Title
Cmax of absolute [13C]urea in plasma

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doris Neuenhofer, MD
Organizational Affiliation
CRS Clinical Research Services Mönchengladbach GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRS Clinical Research Services Mönchengladbach GmbH
City
Mönchengladbach
ZIP/Postal Code
41061
Country
Germany

12. IPD Sharing Statement

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

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