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Completed

NCT Number: NCT01158625

Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes

The purpose of this study is to investigate if it is possible to lower the nighttime blood pressure in patients with type 2 diabetes mellitus by shifting the administration of antihypertensive drugs from morning to nighttime.

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Aarhus, Denmark

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About this study

In recent years several studies have shown that high nighttime blood pressure is associated with increased cardiovascular risk independently of the average 24 hour blood pressure. As a consequence there has been increasing focus on nighttime blood pressure and how to lower it. One way of addressing the problem is to shift the administration of antihypertensive drugs from morning to nighttime. Studies on non-diabetic patients show that by doing this the nighttime blood pressure can be lowered with 3-5 mm Hg without negative effect on the 24 hour blood pressure.

Only recently a study was made on diabetic patients. This showed similar results as for non-diabetic patients.However this study was based on diabetic patients who did not receive any antihypertensive drugs before.

This study will investigate the effects on nighttime blood pressure when shifting administration of antihypertensive drugs from morning to nighttime. The population is diabetic patients who are already in antihypertensive treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes
  • Systolic nighttime blood pressure above 120 mm Hg
  • Systolic daytime blood pressure not exceeding 150 mm Hg
  • Antihypertensive treatment which must include
  • once-daily drugs
  • at least one drug must be a Angiotensin-Converting Enzyme Inhibitor, Angiotensin II Receptor Blocker or Renin Inhibitor.

Exclusion criteria

  • MI or stroke within 6 months
  • heart failure (EF < 45 %)
  • atrial fibrillation
  • eGFR < 30 ml/min

Treatment and study plan

Change of time of administration

Other

Change of time of administration

Primary outcomes

  1. Blood pressure, nighttime blood pressure and 24 h blood pressure

    Time frame: After 16 weeks

Secondary outcomes

  1. Urine albumin excretion

    Time frame: After 16 weeks

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Central Denmark Region
  • Regionshospitalet Silkeborg
  • The Ministry of Science, Technology and Innovation, Denmark

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 8, 2010
Registry last updated
Apr 4, 2013

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.

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