Effect of Aldosterone Blockade on Arterial Compliance

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

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2007-06-30

Brief Summary

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The present study investigated the long-term (12 months) effect of spironolactone treatment on glucose homeostasis, metabolic parameters and vascular properties.

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Detailed Description

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Conditions

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Arterial Stiffness Arterial Elasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Aldosteron blokade, Arterial stiffness, Glucose homeostasis

Group Type EXPERIMENTAL

Spironolactone

Intervention Type DRUG

Spironolactone orally, at a dose of 50 mg/day for 12 months

Interventions

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Spironolactone

Spironolactone orally, at a dose of 50 mg/day for 12 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. patients with type 2 diabetes mellitus

Exclusion Criteria

1. history of unstable angina, myocardial infarction (MI), cerebrovascular accident (CVA)
2. major surgery within the six months preceding entrance to the study
3. unbalanced endocrine disease
4. any disease that might affect absorption of medications
5. plasma creatinine \>2.5 mg/dl
6. elevation of liver enzymes to more that twice the upper normal limit
7. plasma potassium levels \>5.5 mg/dl

Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No