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

South Danish Hypertension and Diabetes Study

Sponsors

Lead Sponsor: Ib Abildgaard Jacobsen

Source Odense University Hospital
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.

Overall Status Completed
Start Date 2010-03-01
Completion Date 2012-05-01
Primary Completion Date 2012-03-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change of of Systolic Blood Pressure 4 months
Change of Diastolic Blood Pressure 4 months
Secondary Outcome
Measure Time Frame
Adverse Effects 4 months
Enrollment 119
Condition
Intervention

Intervention Type: Drug

Intervention Name: spironolactone

Description: 25 to 50 mg once daily

Arm Group Label: addition of spironolactone

Intervention Type: Drug

Intervention Name: placebo

Description: addition of placebo 1 to 2 tablets daily

Arm Group Label: Placebo

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Ib A Jacobsen, DMSc Principal Investigator Odense University Hospital
Verification Date

2014-04-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Odense University Hospital

Investigator Full Name: Ib Abildgaard Jacobsen

Investigator Title: Consultant physician, associate professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: addition of spironolactone

Type: Experimental

Description: spironolactone is added to previous antihypertensive treatment

Label: Placebo

Type: Placebo Comparator

Description: Addition of placebo

Acronym SDHDS
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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