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CompletedNCT00410085Updated Apr 22, 2008

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

A Phase 4 interventional study of L-NMMA (N-mono.methyl-L-arginine) in Obstructive Sleep Apnea and Healthy, sponsored by Regional Hospital Holstebro. Completed at 1 site in Denmark. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-04-22.

Sponsored by Regional Hospital Holstebro · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obstructive Sleep Apnea
  • Healthy
03

In context

Sleep Apnea, Obstructive

2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.

This study's enrollment of 40 is below the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Regional Hospital Holstebro is the lead sponsor of 52 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Obstructive sleep apnea

Exclusion criteria

Exclusion Criteria:

  • Drug or alcohol abuse
  • Pregnancy
  • Disease of the heart, lungs, liver, kidney or endocrine organs
  • Cerebral infarction
  • Diabetes
  • Gastrointestinal disease
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single
Enrollment
40 participants
06

Study locations

1 site
  • Department of Medical Research, Holstebro Hospital
    Holstebro, Ringkoebing County 7500, Denmark
07

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2005 and a completion of Nov 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 10, 2006
First posted
Dec 12, 2006
Start
Jan 2005
Completion
Nov 2005
Last update
Apr 22, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Apr 22, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00410085
Lead sponsor
Regional Hospital Holstebro
First posted
Dec 12, 2006
Start date
Jan 2005
Completion
Nov 2005
Last update
Apr 22, 2008

Study contacts

Erling B Pedersen, Professor
study chair · Regional Hospital Holstebro
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Omega-N-Methylarginine

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