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Aldosterone in Diabetic Nephropathy (ALDODN)

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.
 
ClinicalTrials.gov Identifier: NCT00870402
Recruitment Status : Unknown
Verified March 2009 by Universidad de los Andes, Chile.
Recruitment status was:  Recruiting
First Posted : March 27, 2009
Last Update Posted : March 27, 2009
Sponsor:
Information provided by:
Universidad de los Andes, Chile

Study Description
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Brief Summary:
The purpose of this study is to determine whether spironolactone are effective in the reduction of albuminuria and diastolic disfunction of subjects with diabetic nephropathy.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: Spironolactone Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Aldosterone Antagonism in the Reduction of Albuminuria and Diastolic Disfunction of Patients With Diabetic Nephropathy.
Study Start Date : March 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Spironolactone
25 mg per day for 9 months
Placebo Comparator: 2 Drug: Placebo
Placebo 1 tablet per day for nine months


Outcome Measures
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Primary Outcome Measures :
  1. Reduction of albuminuria [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Reduction of diastolic disfunction [ Time Frame: 9 months ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetic subjects with maximum ten years after diagnostic
  • Diabetic nephropathy with albuminuria
  • Normal renal function
  • Diastolic disfunction
  • Taking a IECA or ARA drug family previously

Exclusion Criteria:

  • Diabetics subjects with macroangiopathy
  • Acute coronary syndrome in the three months before
  • Hyperkalemia > 5.5 mEq/L
  • Pregnancy
Contacts and Locations
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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): NCT00870402


Contacts
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Contact: Francisco G Espinoza, MD 56 - 2 -91380529 ext 000 fespinoz@mi.cl

Locations
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Chile
University of Los Andes Recruiting
Santiago, Chile, 762000
Contact: Helia M Morales, MD    56 - 2 - 93381451 ext 000    heliamorales@gmail.com   
Principal Investigator: Francisco G Espinoza, MD         
Sponsors and Collaborators
Universidad de los Andes, Chile
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Francisco Espinoza Villegas, Departament of Internal Medicine, University of los Andes
ClinicalTrials.gov Identifier: NCT00870402    
Other Study ID Numbers: SA08I20032
First Posted: March 27, 2009    Key Record Dates
Last Update Posted: March 27, 2009
Last Verified: March 2009
Keywords provided by Universidad de los Andes, Chile:
aldosterone
albuminuria
diastolic disfunction
hyperkalemia
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Spironolactone
 Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents