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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00410085
Recruitment Status : Completed
First Posted : December 12, 2006
Last Update Posted : April 22, 2008
Information provided by:
Regional Hospital Holstebro

Brief Summary:

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 or disease Intervention/treatment Phase
Obstructive Sleep Apnea Healthy Drug: L-NMMA (N-mono.methyl-L-arginine) Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Basic Science
Study Start Date : January 2005
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00410085

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

Responsible Party: Pia H Gjørup, Department of Medical Research, Holstebro Hospital Identifier: NCT00410085     History of Changes
Other Study ID Numbers: MED.RES.HOS.2004.03.PHH
First Posted: December 12, 2006    Key Record Dates
Last Update Posted: April 22, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases