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Clinical Trial Details

Trial ID: L3416
Source ID: NCT03917758
Associated Drug: Sglt2 Inhibitor
Title: Antidiuretic Function Before and During Treatment With SGLT2 Inhibitors
Acronym: GliRACo1
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Arterial Hypertension|Body Weight Changes
Interventions: DRUG: SGLT2 inhibitor
Outcome Measures: Primary: Changes from baseline of antidiuretic function parameters (BNP), Blood samples for BNP (pg/mL)., Before starting SGLT2i and 30 days the starting SGLT2i therapy|Changes from baseline of antidiuretic function parameters (BNP), Blood samples for BNP (pg/mL)., 90 days after starting SGLT2i therapy|Changes from baseline of antidiuretic function parameters (vasopressin), Blood samples for Copeptin (pmol/L)., Before starting SGLT2i and 30 days the starting SGLT2i therapy|Changes from baseline of antidiuretic function parameters (vasopressin), Blood samples for Copeptin (pmol/L)., 90 days after starting SGLT2i therapy|Changes from baseline of antidiuretic function parameters (osmolality), Samples for plasma osmolality (mOsm/Kg)., Before starting SGLT2i and 30 days the starting SGLT2i therapy|Changes from baseline of antidiuretic function parameters (osmolality), Samples for urinary osmolality (mOsm/Kg)., Before starting SGLT2i and 30 days the starting SGLT2i therapy|Changes from baseline of antidiuretic function parameters (osmolality), Samples for plasma osmolality (mOsm/Kg)., 90 days after starting SGLT2i therapy|Changes from baseline of antidiuretic function parameters (osmolality), Samples for urinary osmolality (mOsm/Kg)., 90 days after starting SGLT2i therapy|Changes from baseline of antidiuretic function parameters (sodium balance), Samples for serum sodium (mmol/L)., 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)., 90 days after starting SGLT2i therapy|Changes from baseline of antidiuretic function parameters (sodium balance), Samples for urinary sodium (mmol/L)., 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)., 90 days after starting SGLT2i therapy|Changes from baseline of antidiuretic function parameters (potassium balance), Samples for serum potassium (mmol/L)., 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)., 90 days after starting SGLT2i therapy|Changes from baseline of antidiuretic function parameters (potassium balance), Samples for urinary potassium (mmol/L)., 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)., 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)., 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)., 90 days after starting SGLT2i therapy|Long term changes from baseline of renin-angiotensin-aldosterone system parameters aldosterone), Blood samples for aldosterone (pg/mL)., 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), 90 days after starting SGLT2i therapy | Secondary: Changes from baseline of blood pressure values (ABPM), Mean Systolic and Diastolic Blood Pressure (mmHg), Before starting SGLT2i and 90 days after the starting|Changes from baseline of body composition, Variation of parameters of Bioelectrical Impedance Analysis (BIA), Before starting SGLT2i and 90 days after the starting|Changes in basal glicemic control, Blood samples for basal glucose (mg/dL)., Before starting SGLT2i and 90 days after the starting|Changes in long term glicemic control, Blood samples for Glycated albumin (mmol/mol)., Before starting SGLT2i and 90 days after the starting
Sponsor/Collaborators: Sponsor: University of Turin, Italy
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2018-10-10
Completion Date: 2020-10-30
Results First Posted:
Last Update Posted: 2020-11-03
Locations: Mauro Maccario, Torino, Piemonte, 10126, Italy
URL: https://clinicaltrials.gov/show/NCT03917758