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

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ClinicalTrials.gov Identifier: NCT01089309
Recruitment Status : Completed
First Posted : March 18, 2010
Last Update Posted : March 29, 2010
Sponsor:
Information provided by:
Wolfson Medical Center

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

Condition or disease Intervention/treatment Phase
Arterial Stiffness Arterial Elasticity Drug: Spironolactone Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Aldosterone Blockade on Metabolic Parameters and Arterial Compliance
Study Start Date : May 2004
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aldosteron blokade, Arterial stiffness, Glucose homeostasis Drug: Spironolactone
Spironolactone orally, at a dose of 50 mg/day for 12 months





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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
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

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

ClinicalTrials.gov Identifier: NCT01089309     History of Changes
Other Study ID Numbers: WolfsonMC-2004-388
First Posted: March 18, 2010    Key Record Dates
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