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

NCT00843388 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2009-02-13

No results posted yet for this study

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

Interventions

DRUG

Spironolacton (hexalacton(R))

Tablet Spironolacton 25 mg OD

DRUG

placebo tablet

placebo tablet 25 mg OD

Sponsors & Collaborators

  • Steno Diabetes Center Copenhagen

    lead OTHER

Principal Investigators

  • stine e nielsen, MD · Steno Diabetes Center Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-03-31
Completion
2010-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00843388 on ClinicalTrials.gov