Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes

Study Overview
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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.

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.

Official Title
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Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2, Hypertension

Intervention / Treatment
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* Other: Change of time of administration


Participation Criteria
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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. Exclusion Criteria: MI or stroke within 6 months heart failure (EF < 45 %) atrial fibrillation eGFR < 30 ml/min

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Morning dosing of antihypertensive drugs<br> | |
| Active Comparator: Nighttime dosing of antihypertensive drugs<br> | Other: Change of time of administration<br>* Change of time of administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure, nighttime blood pressure and 24 h blood pressure |  | After 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine albumin excretion |  | After 16 weeks |