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Spironolactone in Diabetic Nephropathy

NCT ID: NCT00317954

Last Updated: 2006-04-25

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2005-07-31

Brief Summary

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The aim of the study was to evaluate the renoprotective effect (i.e. albuminuria- and bloodpressure lowering effect) of spironolactone 25 mg o.d. in type 1 and type 2 diabetic patients with albuminuria despite recommended antihypertensive treatment.

Detailed Description

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Conditions

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Diabetic Nephropathy

Keywords

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Diabetic nephropathy Spironolactone Aldosterone antagonism Renoprotection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Spironolactone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diabetes Mellitus
* Diabetic Nephropathy
* Glomerular filtration rate \> 30 ml/min/1.73 m2
* Blood pressure \> 130/80 mm Hg

Exclusion Criteria

* Child bearing potential
* Plasma-potassium \>4.5 mmol/l
* Breastfeeding
* Abuse of alcohol or drugs
* Non-diabetic kidney disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Steno Diabetes Center Copenhagen

OTHER

Sponsor Role lead

Principal Investigators

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Hans-Henrik Parving, MD,DMSc,Prof

Role: STUDY_CHAIR

Steno Diabetes Center Copenhagen

Katrine J Schjoedt, MD

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center Copenhagen

Locations

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Steno Diabetes Center

Gentofte Municipality, , Denmark

Site Status

Countries

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Denmark

References

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Schjoedt KJ, Rossing K, Juhl TR, Boomsma F, Rossing P, Tarnow L, Parving HH. Beneficial impact of spironolactone in diabetic nephropathy. Kidney Int. 2005 Dec;68(6):2829-36. doi: 10.1111/j.1523-1755.2005.00756.x.

Reference Type RESULT
PMID: 16316360 (View on PubMed)

Rossing K, Schjoedt KJ, Smidt UM, Boomsma F, Parving HH. Beneficial effects of adding spironolactone to recommended antihypertensive treatment in diabetic nephropathy: a randomized, double-masked, cross-over study. Diabetes Care. 2005 Sep;28(9):2106-12. doi: 10.2337/diacare.28.9.2106.

Reference Type RESULT
PMID: 16123474 (View on PubMed)

Other Identifiers

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2612-2233

Identifier Type: -

Identifier Source: org_study_id