The Effect of Spironolactone on Blood Pressure in Type-2 Diabetics With Resistant Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to estimate the effect of spironolactone on blood pressure resistant to therapy in type-2 diabetics.

Detailed Description
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The primary object of the study is to estimate the effect of addition of low dose spironolactone to antihypertensive treatment with at least three antihypertensive drugs in patients with type-2 diabetes and blood pressure over 130/80 mmHg. Secondary aims are to estimate how many of these patients have their blood pressure controlled by the addition of spironolactone, to investigate whether the addition of spironolactone affects insulin sensitivity and urinary protein secretion and to estimate the incidence of adverse effects of the aldosterone antagonist.

Official Title
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South Danish Hypertension and Diabetes Study

Conditions
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Arterial Hypertension, Hypertension, Resistant to Conventional Therapy, Diabetes Mellitus

Intervention / Treatment
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* Drug: spironolactone
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age < 75 years Type-2 diabetes Therapy resistant hypertension (by ABPM) Treatment with at least 3 antihypertensives Exclusion Criteria: HbA1c > 10.0 BP > 180/110 mmHg Secondary hypertension Intolerance to spironolactone Permanent treatment with nonsteroidal antiinflammatory drugs or systemic glucocorticoids Total cholesterol 10 mmol/l New York Heart Association class III and IV Pregnancy or planned pregnancy Psychiatric disease Malignant disease Insufficient adherence

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: addition of spironolactone<br>spironolactone is added to previous antihypertensive treatment | Drug: spironolactone<br>* 25 to 50 mg once daily<br>|
| Placebo Comparator: Placebo<br>Addition of placebo | Drug: placebo<br>* addition of placebo 1 to 2 tablets daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of of Systolic Blood Pressure | Change of systolic blood pressure from baseline to study end at four months. | 4 months | 
| Change of Diastolic Blood Pressure | Change of diastolic blood pressure from baseline to study end at four months. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Effects |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, spironolactone, antihypertensive treatment, Type-2 diabetes