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Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes

University of Aarhus logo

University of Aarhus

Status

Completed

Conditions

Hypertension
Diabetes Mellitus, Type 2

Treatments

Other: Change of time of administration

Study type

Interventional

Funder types

Other

Identifiers

NCT01158625
M-20100084

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

46 participants in 2 patient groups

Morning dosing of antihypertensive drugs
No Intervention group
Nighttime dosing of antihypertensive drugs
Active Comparator group
Treatment:
Other: Change of time of administration

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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