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

NCT ID: NCT01774994

Last Updated: 2013-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Study Groups

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stable isotopes

stable isotope infusion for measurement of metabolism

Group Type EXPERIMENTAL

stable isotope infusion for measurement of metabolism

Intervention Type OTHER

Interventions

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stable isotope infusion for measurement of metabolism

Intervention Type OTHER

Eligibility Criteria

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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"
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolaas E Deutz, MD PhD

Role: PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 23011059 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19841582 (View on PubMed)

Other Identifiers

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MEC04-021.3

Identifier Type: -

Identifier Source: org_study_id

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