Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes

Hypertension Clinical Trial

Official title:

Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158625
• Other study ID #: M-20100084
• Status: Completed
• Phase: N/A
• First received: June 25, 2010
• Last updated: April 3, 2013
• Start date: August 2010
• Est. completion date: November 2012

Study information

• Verified date: April 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Hypertension

Intervention

Other:
• Change of time of administration
Change of time of administration

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	Regional Hospital Silkeborg	Silkeborg

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Central Denmark Region, Regionshospitalet Silkeborg, The Ministry of Science, Technology and Innovation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure, nighttime blood pressure and 24 h blood pressure		After 16 weeks	No
Secondary	Urine albumin excretion		After 16 weeks	No