Aldosterone in Diabetic Nephropathy (ALDODN)

March 25, 2009 updated by: Universidad de los Andes, Chile

Effect of Aldosterone Antagonism in the Reduction of Albuminuria and Diastolic Disfunction of Patients With Diabetic Nephropathy.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Francisco G Espinoza, MD
  • Phone Number: 000 56 - 2 -91380529
  • Email: fespinoz@mi.cl

Study Locations

  • Chile
      • Santiago, Chile, 762000
        • Recruiting
        • University of Los Andes
        • Contact:
        • Principal Investigator:
          • Francisco G Espinoza, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of albuminuria
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction of diastolic disfunction
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de los Andes, Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

March 25, 2009

First Submitted That Met QC Criteria

March 25, 2009

First Posted (Estimate)

March 27, 2009

Study Record Updates

Last Update Posted (Estimate)

March 27, 2009

Last Update Submitted That Met QC Criteria

March 25, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SA08I20032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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