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

Primary Purpose

Obstructive Sleep Apnea, Healthy

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

L-NMMA (N-mono.methyl-L-arginine)

About this trial

This is an interventional basic science trial for Obstructive Sleep Apnea

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Medical Research, Holstebro Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00410085

First Posted

December 10, 2006

Last Updated

April 17, 2008

Sponsor

Regional Hospital Holstebro

1. Study Identification

Unique Protocol Identification Number

NCT00410085

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Regional Hospital Holstebro

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea, Healthy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Single

Allocation

Randomized

Enrollment

40 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

L-NMMA (N-mono.methyl-L-arginine)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erling B Pedersen, Professor

Organizational Affiliation

Regional Hospital Holstebro

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Medical Research, Holstebro Hospital

City

Holstebro

State/Province

Ringkoebing County

ZIP/Postal Code

7500

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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