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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
History of Changes
  Purpose

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


Condition Intervention Phase
Arterial Stiffness
Arterial Elasticity
 Drug: Spironolactone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Aldosterone Blockade on Metabolic Parameters and Arterial Compliance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wolfson Medical Center:

Enrollment: 51
Study Start Date: May 2004
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aldosteron blokade, Arterial stiffness, Glucose homeostasis Drug: Spironolactone
Spironolactone orally, at a dose of 50 mg/day for 12 months

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01089309

Locations
Israel
Wolfson Medical Center
Holon, Israel, 58100
Sponsors and Collaborators
Wolfson Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01089309     History of Changes
Other Study ID Numbers: WolfsonMC-2004-388
Study First Received: March 7, 2010
Last Updated: March 26, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Wolfson Medical Center:
Aldosterone Blockade
Arterial elasticity
Glycemic control

Additional relevant MeSH terms:
Spironolactone
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
 Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013