Hypertension in Type 2 Diabetes Clinical Trial
Official title:
The Effect of Device-guided Breathing Exercises on Blood Pressure in Diabetic Patients With Hypertension (Resperate-3) A Randomized, Double-blind Controlled Trial
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 hypertension is the use of breathing exercises. The investigators' previous
studies with a breathing device did not show any positive results. However, these studies
and other trials investigating the effects of breathing devices had not a double-blind
design. Therefore, the investigators want to perform a randomized, double-blind, controlled
trial in a population of T2DM patients.
Objective: To determine the effect of a device slowing breathing (Resperate©) on office
systolic blood pressure (SBP) in diabetic patients with treated hypertension with moderate
BP control.
Study design: A randomized, double-blind, controlled trial.
Study population: Patients with type 2 diabetes mellitus, over 18 years old and a baseline
systolic blood pressure between 140-160 mm Hg.
Intervention: One group receives treatment with a breathing device (Resperate©) and the
other group receives treatment with a "control" breathing device. The latter device does not
try to alter the breathing pattern.
Main study parameters/endpoints: The effect of the breathing device on SBP is the main study
parameter. Secondary endpoints include diastolic blood pressure (DBP) and quality of life.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment