Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2; Hypertension
• Interventions: Other: Change of time of administration

• Registration Number: NCT01158625
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2010-06-25
• Study First Submitted QC: 2010-07-07
• Study First Posted: 2010-07-08
• Study Start: 2010-08
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-03
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nighttime dosing of antihypertensive drugs	Change of time of administration	-

Primary Outcome Measures

Name	Time	Method
Blood pressure, nighttime blood pressure and 24 h blood pressure	After 16 weeks

Secondary Outcome Measures

Name	Time	Method
Urine albumin excretion	After 16 weeks

Trial Locations

Locations (2)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Regional Hospital Silkeborg; 🇩🇰 Silkeborg, Denmark