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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: stable isotope infusion for measurement of metabolism

• Registration Number: NCT01774994
• Lead Sponsor: Maastricht University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2005-01
• Study Completion: 2012-06
• Status Verified: 2013-01
• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-23
• Last Update Submitted: 2013-01-23
• Study First Posted: 2013-01-24
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
stable isotopes	stable isotope infusion for measurement of metabolism	stable isotope infusion for measurement of metabolism

Primary Outcome Measures

Name	Time	Method
whole body NO synthesis	2 hours	postabsorptive nitric oxide synthesis measured by using stable isotope methodology

Secondary Outcome Measures

Name	Time	Method
whole body protein metabolism	2 hours	postabsorptive whole body protein metabolism (protein synthesis, breakdown, net protein breakdown) measured by using stable isotope methodology
whole body arginine metabolism	2 hours	postabsorptive arginine metabolism measured by using stable isotope methodology
blood parameters	2 hours	postabsorptive blood levels (glucose, insulin, urea, amino acids, CRP)