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

• Status: Unknown status
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Steno Diabetes Center; Steno Diabetes Center Copenhagen

Criteria

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