Blood Pressure, Cardiac Hypertrophy, Diabetes Mellitus, Type 2, Hypertension, Microalbuminuria, Obesity, Vascular Stiffness
Conditions
Brief summary
New strategies trying to achieve blood pressure control and consequently reduce cardiovascular risk in resistant hypertensive subjects are promising. In this context, the SGLT2 inhibitor dapagliflozin, not yet investigated in resistant hypertension, arises as a potential drug in order to impact on blood pressure levels, as well as target organ damage and adiposity in this high-risk population.
Detailed description
Objective: The investigators aim to assess whether the intervention with the SGLT2 inhibitor -dapaglifozin - reduces PA levels, target organ damage, fat profile and change the adipokines levels in patients with resistant hypertension with DM2. Methods and design: This crossover randomized, double-blind, interventional study controlled by standard therapy will include 20 patients with resistant hypertension and type 2 diabetes, followed in Outpatient Clinic specialized in Resistant Hypertension at clinical Hospital-UNICAMP. They will be randomly assigned into two groups (1) initially treated with dapagliflozin in combination with their usual antihypertensive therapy and metformin, at 12 weeks (n = 10) or group (2) Control initially treated with glibenclamide at a dose of 5mg daily in combination with antihypertensive therapy usual and metformin, at 12 weeks (n = 10). Office ambulatory and home BP measurements; anthropometric measurements, determination of vascular stiffness by pulse wave velocity, echocardiogram, body bioimpedance, enzyme immunoassays for the determination of adipokines, and lab tests to evaluate biochemical parameters will be performed pre- and after the use of both treatments. Glycemic parameters, and weight will be assessed every 4 weeks. Results and conclusion: The use of SGLT2 inhibitor in these patients may provide new strategies for treatment of patients with resistant hypertension.
Interventions
DRUGDapagliflozin 10mg
Dapagliflozin at a dose of 10mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks
DRUGGlibenclamide 5Mg Tablet
Glibenclamide at a dose of 5mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks
Sponsors
Fundação de Amparo à Pesquisa do Estado de São Paulo
University of Campinas, Brazil
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
Two-way crossover design
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Resistant hypertension and type 2 diabetes diagnoses after a 6-month follow-up * Use of metformin therapy * Therapy adherence * Agree to participate in the research protocol and sign the informed consent form
Exclusion criteria
* secondary Hypertension * pseudoresistance hypertension (poor medication adherence and white coat hypertension) * patients with symptomatic ischemic heart disease, impaired renal function, liver disease and history of stroke, myocardial infarction and peripheral vascular diseases * pregnancy * smoking * autoimmune diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure | Baseline and 12 weeks | Change in Office Systolic Blood Pressure after 12 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ambulatory Systolic Blood Pressure | Baseline and 12 weeks | Change in Ambulatory Systolic Blood Pressure after 12 weeks of treatment |
| Change in weight | Baseline and 12 weeks | Change in body weight |
| Change in arterial stiffness | Baseline and 12 weeks | Change in arterial stiffness measured by Sphygmocor device |
| Change in left ventricular hypertrophy | Baseline and 12 weeks | Change in left ventricular hypertrophy measured by Echocardiogram |
| Change in microalbuminuria | Baseline and 12 weeks | Change in microalbuminuria measured by Urine Albumin/Creatinine Ratio |
Countries
Brazil
Outcome results
None listed