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

Phase 4

• Conditions: Diabetes Mellitus; Nephropathy; Blood Pressure
• Interventions: Drug: Spironolacton (hexalacton(R)); Drug: placebo tablet

• Registration Number: NCT00843388
• Lead Sponsor: Steno Diabetes Center Copenhagen

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-01
• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-02-12
• Last Update Submitted: 2009-02-12
• Study First Posted: 2009-02-13
• Last Update Posted: 2009-02-13
• Study Start: 2009-03
• Primary Completion: 2010-03
• Study Completion: 2010-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• type 1 diabetes
• age 18-80 years
• microalbuminuria

Exclusion Criteria

• blood pressure> 160/100 mmHg
• persistent macroalbuminuria
• pregnancy or in risc of this
• P-Potassium>5.7 mmol/l
• Eplerone treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Spironolacton (hexalacton(R))	60 days treatment with tablet hexalacton 25 mg OD.
2	placebo tablet	Inactive drug of 25 mg OD

Primary Outcome Measures

Name	Time	Method
albuminuria, expected decrease	60 days

Secondary Outcome Measures

Name	Time	Method
GFR	60 days
ambulatory blood pressure	60 days
plasma renin, angiotensin, aldosteron	60 days