NCT00843388

A Crossover Study With Hexalacton in Patients With Type 1 Diabetes and Microalbuminuria

A Randomized Doubleblind Placebo Controlled Crossover Study With Hexalacton in Patients With Type 1 Diabetes and Microalbuminuria

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Steno Diabetes Center Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A double blind, randomized, cross over study in type 1 diabetic patients. 20 patients, age 18-65 years is treated with spironolacton (Hexalacton (R)) for 60 days followed by 60 days treatment with placebo(or opposite). Primary aim: albuminuria, an expected decrease during hexalacton treatment. Secondary aim: ambulatory blood pressure, GFR, plasma-renin, angiotensin, aldosteron.

Conditions

• Diabetes Mellitus
• Nephropathy
• Blood Pressure

Interventions

Type	Name	Description
DRUG	Spironolacton (hexalacton(R))	Tablet Spironolacton 25 mg OD
DRUG	placebo tablet	placebo tablet 25 mg OD

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-02-13
• Last updated: 2009-02-13