CClinicalTrials.gg
Sign In
CompletedNCT01774994Updated Jan 24, 2013

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

An interventional study of stable isotope infusion for measurement of metabolism in Healthy, sponsored by Maastricht University Medical Center. Completed. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-01-24.

Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • volunteers
03

In context

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Written informed consent
  • Age 18-25 years (young); 50-70 years (middle aged/elderly)

Exclusion criteria

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"
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Enrollment
33 participants (actual)

Study arms

  • Experimental
    stable isotopes

    stable isotope infusion for measurement of metabolism

    Other: stable isotope infusion for measurement of metabolism

Interventions

  • Otherstable isotope infusion for measurement of metabolism
06

What researchers measure

Primary outcomes

  1. whole body NO synthesis

    postabsorptive nitric oxide synthesis measured by using stable isotope methodology

    Time frame: 2 hours

Secondary outcomes

  1. whole body protein metabolism

    postabsorptive whole body protein metabolism (protein synthesis, breakdown, net protein breakdown) measured by using stable isotope methodology

    Time frame: 2 hours

  2. whole body arginine metabolism

    postabsorptive arginine metabolism measured by using stable isotope methodology

    Time frame: 2 hours

  3. blood parameters

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

    Time frame: 2 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 23011059 ↗
  • 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. PubMed 19841582 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01774994
Lead sponsor
Maastricht University Medical Center
Responsible party
Sponsor
First posted
Jan 24, 2013
Start date
Nov 2004
Primary completion
Jan 2005
Completion
Jun 2012
Last update
Jan 24, 2013

Study contacts

Nicolaas E Deutz, MD PhD
principal investigator

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Maastricht University Medical Center

Start the discussion