Arginine and Nitric Oxide (NO) Metabolism in Healthy Human Volunteers

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.

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

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"

Treatment and study plan

stable isotope infusion for measurement of metabolism

Other

Primary outcomes

whole body NO synthesis

Time frame: 2 hours

postabsorptive nitric oxide synthesis measured by using stable isotope methodology

Secondary outcomes

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
whole body arginine metabolism

Time frame: 2 hours

postabsorptive arginine metabolism measured by using stable isotope methodology
blood parameters

Time frame: 2 hours

postabsorptive blood levels (glucose, insulin, urea, amino acids, CRP)

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2012
First posted: Jan 24, 2013
Registry last updated: Jan 24, 2013

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.

Published trials that share one or more normalized conditions with this study.

Completed