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Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Regionshospitalet Silkeborg
The Ministry of Science, Technology and Innovation, Denmark
The Health Research Fund of Central Denmark Region
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01158625
First received: June 25, 2010
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urine albumin excretion [ Time Frame: After 16 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
The Health Research Fund of Central Denmark Region
Investigators
Study Director: Klavs W Hansen, MD, DrMedSc Department of Medicine, Regional Hospital Silkeborg
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01158625     History of Changes
Other Study ID Numbers: M-20100084
Study First Received: June 25, 2010
Last Updated: April 3, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013