Skip to main content
OpenTrials
Completed

NCT Number: NCT01062763

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arterial Hypertension Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypertension Hypertension Resistant to Conventional Therapy Hypertension, Resistant to Conventional Therapy Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spironolactone

Drug

25 to 50 mg once daily

Placebo

Drug

addition of placebo 1 to 2 tablets daily

Primary outcomes

  1. Change of of Systolic Blood Pressure

    Time frame: 4 months

    Change of systolic blood pressure from baseline to study end at four months.

  2. Change of Diastolic Blood Pressure

    Time frame: 4 months

    Change of diastolic blood pressure from baseline to study end at four months.

Secondary outcomes

  1. Adverse Effects

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Ib Abildgaard Jacobsen

Other

Registry information

Official study title

South Danish Hypertension and Diabetes Study

Acronym: SDHDS

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 4, 2010
Registry last updated
May 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.