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
Other: 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.

Sponsor

Maastricht University Medical Center

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

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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