Status:
COMPLETED
Device-guided Breathing Exercises on Blood Pressure in Diabetic Patients
Lead Sponsor:
Medical Research Foundation, The Netherlands
Conditions:
Hypertension in Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Rationale: Hypertension is an important risk factor of cardiovascular disease, especially in patients with type 2 diabetes mellitus (T2DM). A relatively recent development for the treatment of hyperte...
Eligibility Criteria
Inclusion
- known T2DM,
- over 18 years old,
- known hypertension with a systolic BP (SBP) between 130-170 mm Hg at the previous visit to the internal outpatient department and at the last visit to the internist (which is the same day as baseline measurement) and treated with one or more anti-hypertensive drugs, which have not been changed for the preceding three months. At baseline the SBP should be between 140-160 mm Hg, measured by the investigator.
Exclusion
- patients with orthostatic hypotension,
- known heart failure (NYHA III-IV) and/or patients with pulmonary disease (for example asthma, chronic obstructive pulmonary disease and pulmonary fibrosis),
- patients with insufficient knowledge of the Dutch language to understand the requirements of the study,
- additional criteria were hospitalization in the past 3 months, deafness, blindness and cognitive abilities deemed insufficient for operation of a study device.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00951119
Start Date
September 1 2009
End Date
June 1 2012
Last Update
October 24 2012
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Isala Clinics, Diabetes Centre
Zwolle, Netherlands, 8000 GM
2
Isala clinics
Zwolle, Netherlands, 8000 GM