Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2 Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Morning dosing of antihypertensive drugs

Group Type NO_INTERVENTION

No interventions assigned to this group

Nighttime dosing of antihypertensive drugs

Group Type ACTIVE_COMPARATOR

Change of time of administration

Intervention Type OTHER

Change of time of administration

Interventions

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Change of time of administration

Intervention Type OTHER

Eligibility Criteria

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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.