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

Information source: Cytonet GmbH & Co. KG
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urea Cycle Disorders

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

Phase: N/A

Status: Completed

Sponsored by: Cytonet GmbH & Co. KG

Official(s) and/or principal investigator(s):
Doris Neuenhofer, MD, Principal Investigator, Affiliation: CRS Clinical Research Services Mönchengladbach GmbH

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.

Clinical Details

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

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

Secondary outcome: Cmax of absolute [13C]urea in plasma

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

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

Locations and Contacts

CRS Clinical Research Services Mönchengladbach GmbH, Mönchengladbach 41061, Germany
Additional Information

Starting date: September 2009
Last updated: January 14, 2010

Page last updated: August 23, 2015

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