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Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01158625
First Posted: July 8, 2010
Last Update Posted: April 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Regionshospitalet Silkeborg
The Ministry of Science, Technology and Innovation, Denmark
Central Denmark Region
Information provided by (Responsible Party):
University of Aarhus
  Purpose
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.

Condition Intervention
Diabetes Mellitus, Type 2 Hypertension Other: Change of time of administration

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Blood pressure, nighttime blood pressure and 24 h blood pressure [ Time Frame: After 16 weeks ]

Secondary Outcome Measures:
  • Urine albumin excretion [ Time Frame: After 16 weeks ]

Enrollment: 46
Study Start Date: August 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Morning dosing of antihypertensive drugs
Active Comparator: Nighttime dosing of antihypertensive drugs Other: Change of time of administration
Change of time of administration

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158625


Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Regional Hospital Silkeborg
Silkeborg, Denmark, 8600
Sponsors and Collaborators
University of Aarhus
Regionshospitalet Silkeborg
The Ministry of Science, Technology and Innovation, Denmark
Central Denmark Region
Investigators
Study Director: Klavs W Hansen, MD, DrMedSc Department of Medicine, Regional Hospital Silkeborg
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01158625     History of Changes
Other Study ID Numbers: M-20100084
First Submitted: June 25, 2010
First Posted: July 8, 2010
Last Update Posted: April 4, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Antihypertensive Agents