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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01089309
First Posted: March 18, 2010
Last Update Posted: March 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wolfson Medical Center
March 7, 2010
March 18, 2010
March 29, 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
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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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Sexes Eligible for Study: All
45 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01089309
WolfsonMC-2004-388
Yes
Not Provided
Not Provided
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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