- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01774994
Arginine and Nitric Oxide (NO) Metabolism in Healthy Human Volunteers
January 23, 2013 updated by: Maastricht University Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Written informed consent
- Age 18-25 years (young); 50-70 years (middle aged/elderly)
Exclusion Criteria:
- 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"
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: stable isotopes
stable isotope infusion for measurement of metabolism
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
whole body NO synthesis
Time Frame: 2 hours
|
postabsorptive nitric oxide synthesis measured by using stable isotope methodology
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
whole body protein metabolism
Time Frame: 2 hours
|
postabsorptive whole body protein metabolism (protein synthesis, breakdown, net protein breakdown) measured by using stable isotope methodology
|
2 hours
|
whole body arginine metabolism
Time Frame: 2 hours
|
postabsorptive arginine metabolism measured by using stable isotope methodology
|
2 hours
|
blood parameters
Time Frame: 2 hours
|
postabsorptive blood levels (glucose, insulin, urea, amino acids, CRP)
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nicolaas E Deutz, MD PhD
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Luiking 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2004
Primary Completion (Actual)
January 1, 2005
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
January 22, 2013
First Submitted That Met QC Criteria
January 23, 2013
First Posted (Estimate)
January 24, 2013
Study Record Updates
Last Update Posted (Estimate)
January 24, 2013
Last Update Submitted That Met QC Criteria
January 23, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MEC04-021.3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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