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| Sponsored by: |
Department of Veterans Affairs |
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00498537 |
Purpose
Introduction: Aldosterone seems to have deleterious effects on the kidneys. Many animal studies and few clinical trials now have shown that suppression of aldosterone by aldosterone receptor blockers ameliorated these effects.
Method: In a double-blind, cross over study, 24 patients with diabetic nephropathy who were already receiving either ACE inhibitor(lisinopril 20-40 mg/day ) or ARB( losartan 25-100 mg/day )were given spironolactone( 25 mg during the first month and 50 mg during the second and third month if serum K remained ok) or matching placebo with 1 month of washout in between. All patients were from a single center and exclusively male veterans. Blood pressure, serum creatinine, serum K and spot urine protein/creatinine were measured at the beginning and end of each study period. The study was started in May of 2003 and completed in May 2006.
| Condition | Intervention |
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Diabetic Nephropathy |
Drug: spironolactone |
| MedlinePlus related topics: | Diabetic Kidney Problems |
| Drug Information available for: | Spironolactone Aldosterone |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Spironolactone for Reducing Proteinuria in Diabetic Nephropathy |
| Enrollment: | 30 |
| Study Start Date: | January 2003 |
| Study Completion Date: | June 2006 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1 | Drug: spironolactone |
| 2 | Drug: spironolactone |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The study is completed. Inclusion criteria was diabetic nephropathy
Exclusion Criteria:
Scr >2 mg/dl and serum K > 5meq/L
Contacts and Locations More Information
| Responsible Party: | Department of Veterans Affairs ( Saklayen, Mohammad - Principal Investigator ) |
| Study ID Numbers: | 0024 |
| First Received: | July 6, 2007 |
| Last Updated: | October 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00498537 |
| Health Authority: | United States: Federal Government |
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