The purpose of this study is to estimate the effect of spironolactone on blood pressure resistant to therapy in type-2 diabetics.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
119
25 to 50 mg once daily
addition of placebo 1 to 2 tablets daily
Change of of Systolic Blood Pressure
Change of systolic blood pressure from baseline to study end at four months.
Time frame: 4 months
Change of Diastolic Blood Pressure
Change of diastolic blood pressure from baseline to study end at four months.
Time frame: 4 months
Adverse Effects
Time frame: 4 months
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