Arginine and Nitric Oxide (NO) Metabolism in Healthy Human Volunteers
1 other identifier
interventional
33
0 countries
N/A
Brief Summary
Investigation of arginine and NO metabolism in healthy subjects is important as a reference for alterations in arginine-NO metabolism in patients. Moreover, this study will indicate the changes during aging and gender-related differences. Although data on arginine metabolism exist in literature, data are limited to young healthy male subjects. Since patients with suspected changes in arginine metabolism, e.g. sepsis and cancer patients are often elderly and also women, knowledge of arginine metabolism in these groups is needed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Nov 2004
Longer than P75 for not_applicable healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 22, 2013
CompletedFirst Posted
Study publicly available on registry
January 24, 2013
CompletedJanuary 24, 2013
January 1, 2013
2 months
January 22, 2013
January 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
whole body NO synthesis
postabsorptive nitric oxide synthesis measured by using stable isotope methodology
2 hours
Secondary Outcomes (3)
whole body protein metabolism
2 hours
whole body arginine metabolism
2 hours
blood parameters
2 hours
Study Arms (1)
stable isotopes
EXPERIMENTALstable isotope infusion for measurement of metabolism
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent
- Age 18-25 years (young); 50-70 years (middle aged/elderly)
You may not qualify if:
- Diabetes mellitus type I
- Livercirrhosis, pancreatitis, malignancies
- Hypertension (diastolic blood pressure \>95 mmHg or systolic blood pressure \>160 mmHg)
- History of gastrointestinal complaints
- Recent involuntary weight loss (more than 10 % in 6 months or more than 5 % in one month)
- Pregnancy (pregnancy test is done in female subjects)
- Use of medication that can affect arginine metabolism (nitrovasodilators and corticosteroids)
- Subjects with "high activity level"
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Luiking YC, Ten Have GA, Wolfe RR, Deutz NE. Arginine de novo and nitric oxide production in disease states. Am J Physiol Endocrinol Metab. 2012 Nov 15;303(10):E1177-89. doi: 10.1152/ajpendo.00284.2012. Epub 2012 Sep 25.
PMID: 23011059BACKGROUNDLuiking YC, Engelen MP, Deutz NE. Regulation of nitric oxide production in health and disease. Curr Opin Clin Nutr Metab Care. 2010 Jan;13(1):97-104. doi: 10.1097/MCO.0b013e328332f99d.
PMID: 19841582BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolaas E Deutz, MD PhD
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2013
First Posted
January 24, 2013
Study Start
November 1, 2004
Primary Completion
January 1, 2005
Study Completion
June 1, 2012
Last Updated
January 24, 2013
Record last verified: 2013-01