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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
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Aldosterone Blockade on Metabolic Parameters and Arterial Compliance

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01089309


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

ClinicalTrials.gov Identifier: NCT01089309     History of Changes
Other Study ID Numbers: WolfsonMC-2004-388
First Submitted: March 7, 2010
First Posted: March 18, 2010
Last Update Posted: March 29, 2010
Last Verified: March 2010

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

Additional relevant MeSH terms:
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents