Conditions: Arterial Hypertension Hypertension, Resistant to Conventional Therapy Diabetes Mellitus
Keywords: hypertension spironolactone antihypertensive treatment Type-2 diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 119
Healthy volunteers: no

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

Detailed description:
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.

Arms:
arm 1: spironolactone is added to previous antihypertensive treatment arm 2: Addition of placebo

Interventions: intervention 1: spironolactone intervention 2: placebo
Intervention descriptions: intervention 1: 25 to 50 mg once daily intervention 2: addition of placebo 1 to 2 tablets daily

Protocol document: