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Completed

NCT Number: NCT01002469

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

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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Key information

Conditions

Urea Cycle Disorders Amino Acid Metabolism, Inborn Errors Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases Urea Cycle Disorders, Inborn

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CRS Clinical Research Services Mönchengladbach GmbH

Mönchengladbach, 41061, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sodium [1-13C] acetate

Other

Primary outcomes

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

Secondary outcomes

  1. Cmax of absolute [13C]urea in plasma

Sponsors and collaborators

Lead sponsor

Cytonet GmbH & Co. KG

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 27, 2009
Registry last updated
Jan 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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