NCT01062763

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

South Danish Hypertension and Diabetes Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Ib Abildgaard Jacobsen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	spironolactone	25 to 50 mg once daily
DRUG	placebo	addition of placebo 1 to 2 tablets daily

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-03-01
• Completion: 2012-05-01
• First posted: 2010-02-04
• Last updated: 2014-05-08
• Results posted: 2014-05-08