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L-NMMA Dose-response Study in Healthy Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
Registration Number
NCT01070940
Lead Sponsor
Regional Hospital Holstebro
Brief Summary

The purpose of this study is to investigate the effect of different levels of nitric oxide inhibition on blood pressure and arterial stiffness in healthy subjects. L-NMMA, an inhibitor of the nitric oxide synthase, is administered as bolus injection followed by continuous infusion, and is expected to raise blood pressure and arterial stiffness according to L-NMMA dose.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
12
Inclusion Criteria
  • Healthy males
  • Age 18-35 years
  • BMI 18.5-30.0
Exclusion Criteria
  • Tobacco or illicit drug use
  • Current use of any prescription or non-prescription drugs
  • Alcohol abuse
  • History of heart failure, lever failure, chronic kidney disease or cerebral insult
  • Diabetes
  • Clinical or paraclinical signs of infection
  • Pathologic ECG
  • Ambulatory blood pressure >140/90 mmHg
  • Abnormal blood or urin screening tests

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Intravenous L-NMMA dose 1NG-monomethyl-L-arginine (L-NMMA)-
Isotonic saline infusionPlacebo-
Intravenous L-NMMA dose 2NG-monomethyl-L-arginine (L-NMMA)-
Intravenous L-NMMA dose 3NG-monomethyl-L-arginine (L-NMMA)-
Primary Outcome Measures
NameTimeMethod
Systolic blood pressure6 hours
Secondary Outcome Measures
NameTimeMethod
GFR6 hours
Arterial Stiffness6 hours
Fractional excretion of sodium6 hours
Fractional excretion of potassium6 hours
Plasma renin concentration6 hour
Plasma angiotensin II6 hours
Plasma aldosterone6 hour

Trial Locations

Locations (1)

Departments of Medical Research

🇩🇰

Holstebro, Denmark

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