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NCT01089309 Clinical Trial

Effect of Aldosterone Blockade on Arterial Compliance

Arterial Stiffness Clinical Trial

— RAAS LAEI SAEI  

Official title:
Effect of Aldosterone Blockade on Metabolic Parameters and Arterial Compliance

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01089309
Other study ID # WolfsonMC-2004-388
Secondary ID
Status Completed
Phase Phase 4
First received March 7, 2010
Last updated March 26, 2010
Start date May 2004
Est. completion date June 2007

Study information
Verified date March 2010
Source Wolfson Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 85 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Israel Wolfson Medical Center Holon

Sponsors (1)
Lead Sponsor Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

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