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

April 8, 2014 updated by: Ib Abildgaard Jacobsen

South Danish Hypertension and Diabetes Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Effects
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ib Abildgaard Jacobsen

Investigators

  • Principal Investigator: Ib A Jacobsen, DMSc, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

February 3, 2010

First Submitted That Met QC Criteria

February 3, 2010

First Posted (Estimate)

February 4, 2010

Study Record Updates

Last Update Posted (Estimate)

May 8, 2014

Last Update Submitted That Met QC Criteria

April 8, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT 2009-017033-22
  • 2009-017033-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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