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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01774994
First received: January 22, 2013
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Healthy
Other: stable isotope infusion for measurement of metabolism

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Basic Science
Official Title: Arginine and Nitric Oxide (NO) Metabolism in Healthy Human Volunteers

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • whole body NO synthesis [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    postabsorptive nitric oxide synthesis measured by using stable isotope methodology


Secondary Outcome Measures:
  • whole body protein metabolism [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    postabsorptive arginine metabolism measured by using stable isotope methodology

  • blood parameters [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    postabsorptive blood levels (glucose, insulin, urea, amino acids, CRP)


Enrollment: 33
Study Start Date: November 2004
Study Completion Date: June 2012
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: stable isotopes
stable isotope infusion for measurement of metabolism
Other: stable isotope infusion for measurement of metabolism

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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"
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774994

Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Nicolaas E Deutz, MD PhD
  More Information

Publications:
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01774994     History of Changes
Other Study ID Numbers: MEC04-021.3
Study First Received: January 22, 2013
Last Updated: January 23, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
volunteers

Additional relevant MeSH terms:
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on July 20, 2014