Subjects treated with Canagliflozin, Dapagliflozin and Empagliflozin obtained improvement on blood pressure values, body weight and cardiovascular mortality but pathophysiological explanations of these effects are not yet known.
The pathophysiological explanations of the cardiovascular improvement of patients treated with SGLT2i are not yet known: osmotic diuresis and natriuresis, direct effects of weight reduction, increased in nitric oxide release, oxidative stress reduction, local renin-angiotensin-aldosterone system (RAAS) inhibition are the supposed mechanism. In the Literature the diuretic effect of SGLT2i therapy seems to be even stronger than thiazide or thiazide-like drugs. However, it is not defined the role of SGLT2i on antidiuretic function (RAAS, brain natriuretic peptide-BNP and antidiuretic hormone-ADH). Defining this relation could be important for: * knowing effect of SGLT2i on RAAS (drugs interferences are important particularly during case detection of primary aldosteronism); * discovering antidiuretic response to SGLT2i treatment and interactions between RAAS, BNP and ADH on the volume improvement induced by this new antidiabetic drugs. In addition the aim of the study is to define effect of treatment on blood pressure and body composition.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
30
Start of the treatment with SGLT2i.
Mauro Maccario
Turin, Piedmont, Italy
RECRUITINGChanges from baseline of antidiuretic function parameters (BNP)
Blood samples for BNP (pg/mL).
Time frame: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (BNP)
Blood samples for BNP (pg/mL).
Time frame: 90 days after starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (vasopressin)
Blood samples for Copeptin (pmol/L).
Time frame: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (vasopressin)
Blood samples for Copeptin (pmol/L).
Time frame: 90 days after starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (osmolality)
Samples for plasma osmolality (mOsm/Kg).
Time frame: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (osmolality)
Samples for urinary osmolality (mOsm/Kg).
Time frame: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (osmolality)
Samples for plasma osmolality (mOsm/Kg).
Time frame: 90 days after starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (osmolality)
Samples for urinary osmolality (mOsm/Kg).
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Time frame: 90 days after starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (sodium balance)
Samples for serum sodium (mmol/L).
Time frame: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (sodium balance)
Samples for serum sodium (mmol/L).
Time frame: 90 days after starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (sodium balance)
Samples for urinary sodium (mmol/L).
Time frame: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (sodium balance)
Samples for urinary sodium (mmol/L).
Time frame: 90 days after starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (potassium balance)
Samples for serum potassium (mmol/L).
Time frame: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (potassium balance)
Samples for serum potassium (mmol/L).
Time frame: 90 days after starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (potassium balance)
Samples for urinary potassium (mmol/L).
Time frame: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Changes from baseline of antidiuretic function parameters (potassium balance)
Samples for urinary potassium (mmol/L).
Time frame: 90 days after starting SGLT2i therapy
Changes from baseline of renin-angiotensin-aldosterone system parameters (renin)
Blood samples for plasma renin activity (ng/mL/h).
Time frame: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Changes from baseline of renin-angiotensin-aldosterone system parameters (renin)
Blood samples for plasma renin activity (ng/mL/h).
Time frame: 90 days after starting SGLT2i therapy
Long term changes from baseline of renin-angiotensin-aldosterone system parameters aldosterone)
Blood samples for aldosterone (pg/mL).
Time frame: Before starting SGLT2i and 30 days the starting SGLT2i therapy
Long term changes from baseline of renin-angiotensin-aldosterone system parameters
Blood samples for plasma renin activity (ng/mL/h) and aldosterone (pg/mL)
Time frame: 90 days after starting SGLT2i therapy
Changes from baseline of blood pressure values (ABPM)
Mean Systolic and Diastolic Blood Pressure (mmHg)
Time frame: Before starting SGLT2i and 90 days after the starting
Changes from baseline of body composition
Variation of parameters of Bioelectrical Impedance Analysis (BIA)
Time frame: Before starting SGLT2i and 90 days after the starting
Changes in basal glicemic control
Blood samples for basal glucose (mg/dL).
Time frame: Before starting SGLT2i and 90 days after the starting
Changes in long term glicemic control
Blood samples for Glycated albumin (mmol/mol).
Time frame: Before starting SGLT2i and 90 days after the starting