We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Spironolactone in Diabetic Nephropathy

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: NCT00317954
Recruitment Status : Completed
First Posted : April 25, 2006
Last Update Posted : April 25, 2006
Sponsor:
Information provided by:
Steno Diabetes Center Copenhagen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The aim of the study was to evaluate the renoprotective effect (i.e. albuminuria- and bloodpressure lowering effect) of spironolactone 25 mg o.d. in type 1 and type 2 diabetic patients with albuminuria despite recommended antihypertensive treatment.

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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Spironolactone in Diabetic Nephropathy
Study Start Date : September 2003
Study Completion Date : July 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Changes in albuminuria
  2. Changes in blood pressure

Secondary Outcome Measures :
  1. Changes in glomerular filtration rate

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes Mellitus
  • Diabetic Nephropathy
  • Glomerular filtration rate > 30 ml/min/1.73 m2
  • Blood pressure > 130/80 mm Hg

Exclusion Criteria:

  • Child bearing potential
  • Plasma-potassium >4.5 mmol/l
  • Breastfeeding
  • Abuse of alcohol or drugs
  • Non-diabetic kidney disease
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00317954


Locations
Layout table for location information
Denmark
Steno Diabetes Center
Gentofte, Denmark, 2820
Sponsors and Collaborators
Steno Diabetes Center Copenhagen
Investigators
Layout table for investigator information
Study Chair: Hans-Henrik Parving, MD,DMSc,Prof Steno Diabetes Center Copenhagen
Principal Investigator: Katrine J Schjoedt, MD Steno Diabetes Center Copenhagen
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00317954    
Other Study ID Numbers: 2612-2233
First Posted: April 25, 2006    Key Record Dates
Last Update Posted: April 25, 2006
Last Verified: August 2005
Keywords provided by Steno Diabetes Center Copenhagen:
Diabetic nephropathy
Spironolactone
Aldosterone antagonism
Renoprotection
Additional relevant MeSH terms:
Layout table for MeSH terms
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