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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Urea Cycle Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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sodium [1-13C] acetate

Group Type EXPERIMENTAL

sodium [1-13C] acetate

Intervention Type OTHER

Interventions

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sodium [1-13C] acetate

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes