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Renal Hemodynamics and Tubular Function in Patients With Obstructive Sleep Apnea and Healthy Controls

This study has been completed.
Sponsor:
Information provided by:
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT00410085
First received: December 10, 2006
Last updated: April 17, 2008
Last verified: April 2008
History of Changes
  Purpose

Nitrogen-oxide (NO) plays an important role for blood pressure regulation, renal hemodynamics, and the renal excretion of sodium. NO is synthesized from L-arginine in the vascular endothelium and have a very short half-life in plasma and is therefore very difficult to measure directly.

L-mono-methyl-L-arginine (L-NMMA) is an analogue to L-arginine and a competitive inhibitor of NO, and therefore can be used to study the effect of NO on the circulation. In normal subjects, infusion of L-NMMA will cause an increase in blood pressure, decreased renal plasma-flow, decreased glomerular filtration rate, and a decreased excretion of sodium.

Hypothesis: Patients with obstructive sleep apnea has a decreased activity in the NO-system. This is contributing to the hypertension often seen in these patients. Decreased activity in the NO-system can be revealed by diminished fall in renal hemodynamic and sodium excretion after infusion of L-NMMA.


Condition Intervention Phase
Obstructive Sleep Apnea
Healthy
 Drug: L-NMMA (N-mono.methyl-L-arginine)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Basic Science

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Arginine
U.S. FDA Resources

Further study details as provided by Regional Hospital Holstebro:

Estimated Enrollment: 40
Study Start Date: January 2005
Estimated Study Completion Date: November 2005
  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Obstructive sleep apnea

Exclusion Criteria:

  • Drug or alcohol abuse
  • Pregnancy
  • Disease of the heart, lungs, liver, kidney or endocrine organs
  • Cerebral infarction
  • Diabetes
  • Gastrointestinal disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00410085

Locations
Denmark
Department of Medical Research, Holstebro Hospital
Holstebro, Ringkoebing County, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
Study Chair: Erling B Pedersen, Professor Regional Hospital Holstebro
  More Information

No publications provided

Responsible Party: Pia H Gjørup, Department of Medical Research, Holstebro Hospital
ClinicalTrials.gov Identifier: NCT00410085     History of Changes
Other Study ID Numbers: MED.RES.HOS.2004.03.PHH
Study First Received: December 10, 2006
Last Updated: April 17, 2008
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013