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CompletedNCT01089309RAAS LAEI SAEIUpdated Mar 29, 2010

Effect of Aldosterone Blockade on Arterial Compliance

A Phase 4 interventional study of Spironolactone in Arterial Stiffness and Arterial Elasticity, sponsored by Wolfson Medical Center. Completed at 1 site in Israel. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2010-03-29.

Sponsored by Wolfson Medical Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
45 Years to 85 Years
Sex
All
01

Study summary

The present study investigated the long-term (12 months) effect of spironolactone treatment on glucose homeostasis, metabolic parameters and vascular properties.

02

Conditions studied

  • Arterial Stiffness
  • Arterial Elasticity

Keywords

  • Aldosterone Blockade
  • Arterial elasticity
  • Glycemic control
03

In context

Lead sponsor

Wolfson Medical Center is the lead sponsor of 118 studies on the registry; 17 are open to participants now.

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

04

Who can participate

Ages eligible
45 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

1. patients with type 2 diabetes mellitus

Exclusion criteria

Exclusion Criteria:

  1. history of unstable angina, myocardial infarction (MI), cerebrovascular accident (CVA)
  2. major surgery within the six months preceding entrance to the study
  3. unbalanced endocrine disease
  4. any disease that might affect absorption of medications
  5. plasma creatinine >2.5 mg/dl
  6. elevation of liver enzymes to more that twice the upper normal limit
  7. plasma potassium levels >5.5 mg/dl
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    Aldosteron blokade, Arterial stiffness, Glucose homeostasis

    Drug: Spironolactone

Interventions

  • DrugSpironolactone

    Spironolactone orally, at a dose of 50 mg/day for 12 months

06

Study locations

1 site
  • Wolfson Medical Center
    Holon, 58100, Israel
07

Timeline

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

The record gives a start of May 2004, a primary completion of Jun 2007 and a completion of Jun 2007. 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
Mar 7, 2010
First posted
Mar 18, 2010
Start
May 2004
Primary completionActual
Jun 2007
CompletionActual
Jun 2007
Last update
Mar 29, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
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.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 29, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01089309
Lead sponsor
Wolfson Medical Center
First posted
Mar 18, 2010
Start date
May 2004
Primary completion
Jun 2007
Completion
Jun 2007
Last update
Mar 29, 2010

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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