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NCT00410085 Clinical Trial

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

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00410085
Other study ID # MED.RES.HOS.2004.03.PHH
Secondary ID
Status Completed
Phase Phase 4
First received December 10, 2006
Last updated April 17, 2008
Start date January 2005
Est. completion date November 2005

Study information
Verified date April 2008
Source Regional Hospital Holstebro
Contact n/a
Is FDA regulated No
Health authority Denmark: The Danish National Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date November 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 65 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• L-NMMA (N-mono.methyl-L-arginine)

Locations
Country Name City State
Denmark Department of Medical Research, Holstebro Hospital Holstebro Ringkoebing County

Sponsors (1)
Lead Sponsor Collaborator
Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

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