Clincosm LogoSign in Get a demo

RAAS LAEI SAEI: Effect of Aldosterone Blockade on Arterial Compliance

Sponsor
Wolfson Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01089309
Collaborator
(none)
51
Enrollment
1
Location
1
Arm
37
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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
Phase 4

Study Design

Study Type:
Interventional
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 1, 2004
Actual Primary Completion Date :
Jun 1, 2007
Actual Study Completion Date :
Jun 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Aldosteron blokade, Arterial stiffness, Glucose homeostasis

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Wolfson Medical Center Holon Israel 58100

    Sponsors and Collaborators

    • Wolfson Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01089309
    Other Study ID Numbers:
    • WolfsonMC-2004-388
    First Posted:
    Mar 18, 2010
    Last Update Posted:
    Mar 29, 2010
    Last Verified:
    Mar 1, 2010
    Keywords provided by , ,
    Aldosterone Blockade
    Arterial elasticity
    Glycemic control
    Additional relevant MeSH terms:
    Spironolactone

    Study Results

    No Results Posted as of Mar 29, 2010