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

NCT ID: NCT00843388

Last Updated: 2009-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-03-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus Nephropathy Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

60 days treatment with tablet hexalacton 25 mg OD.

Group Type ACTIVE_COMPARATOR

Spironolacton (hexalacton(R))

Intervention Type DRUG

Tablet Spironolacton 25 mg OD

2

Inactive drug of 25 mg OD

Group Type PLACEBO_COMPARATOR

placebo tablet

Intervention Type DRUG

placebo tablet 25 mg OD

Interventions

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Spironolacton (hexalacton(R))

Tablet Spironolacton 25 mg OD

Intervention Type DRUG

placebo tablet

placebo tablet 25 mg OD

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Steno Diabetes Center Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Steno Diabetes Center, Dep 520

Principal Investigators

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stine e nielsen, MD

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center Copenhagen

Other Identifiers

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Eudra CT: 2008-004839-38

Identifier Type: -

Identifier Source: secondary_id

2306

Identifier Type: -

Identifier Source: org_study_id

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