Effect of Aldosterone Blockade on Arterial Compliance (RAAS LAEI SAEI)

This study has been completed.
Sponsor:
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01089309
First received: March 7, 2010
Last updated: March 26, 2010
Last verified: March 2010

March 7, 2010
March 26, 2010
May 2004
June 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01089309 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Effect of Aldosterone Blockade on Arterial Compliance
Effect of Aldosterone Blockade on Metabolic Parameters and Arterial Compliance

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Arterial Stiffness
  • Arterial Elasticity
Drug: Spironolactone
Spironolactone orally, at a dose of 50 mg/day for 12 months
Experimental: Aldosteron blokade, Arterial stiffness, Glucose homeostasis
Intervention: Drug: Spironolactone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
June 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

1. patients with type 2 diabetes mellitus

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
Both
45 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01089309
WolfsonMC-2004-388
Yes
Not Provided
Wolfson Medical Center
Not Provided
Not Provided
Wolfson Medical Center
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP