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Clinical Trial Details

Trial ID: L3441
Source ID: NCT05999773
Associated Drug: Sglt2 Inhibitor
Title: SGLT-2 Inhibitors in the Treatment of Ascites
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Ascites Hepatic|Cirrhosis, Liver|Diabete Type 2
Interventions: DRUG: SGLT2 inhibitor
Outcome Measures: Primary: Ascites control, Ascites control, defined in terms of: * Optimal control, in case of total disappearance of the ascites * Reduction of the grade of ascites from grade 2 to grade 1 (i.e. ascites that is clinically undetectable, which does not determine abdominal distension and detectable only by ultrasound). * Absence of response, in case of persistence of ascites of the same degree., Day 0, 4 weeks, 3 months, 6 months|Glycemic control, Reduction of glycosylated hemoglobin (HbA1C) levels from baseline to the end of the study, defined as: * Optimal control: HbA1C below 6.5% * Good control: HbA1C between 6.5% and 6.9% * Inadequate control: HbA1C between 7.0% and 8% * Poor control: HbA1C above 8.0%, Day 0, 4 weeks, 3 months, 6 months|SGLT-2 inhibitors related adverse events, Appearance of any adverse effect related to the intake of an SGLT-2 inhibitor, classified as follows: * None: no adverse effects * Minimal: adverse effect which does not significantly compromise the patient's state of health and which allows the continuation of the therapy * Moderate: adverse effect which significantly compromises the patient's state of health and which does not allow the continuation of the therapy, managed in an outpatient setting. * Severe: adverse effect which significantly compromises the patient's state of health and which does not allow the continuation of the therapy, managed in an inpatient setting. * Life-threatening: adverse effect that puts the patient's life in danger and which requires the immediate interruption of therapy and hospitalization., Day 0, 4 weeks, 3 months, 6 months | Secondary: Fasting glucose control, Fasting blood glucose will be evaluated by finger stick glucose auto measurement after overnight fasting in the 5 days preceding the outpatient visit, and will be classified as: - Good fasting glucose control: average of three consecutive fasting blood glucose measurement between 80-130 mg/dl. Poor glycemic control: average blood glucose measurements of three consecutive fasting blood glucose measurement \>130 or \<70 mg/dl, Day 0, 4 weeks, 3 months, 6 months|Weight loss, Weight reduction will be assessed by weight measurements at day 0, at 4 weeks, 3 months and 6 months, and will be classified as: * Optimal: weight loss \>= 5 kg * Good: 5 Kg\< weight loss =\< 2.5 Kg * Poor: 2.5 Kg\< weight loss \< 0 Kg * Gain: any value of weight gain, Day 0, 4 weeks, 3 months, 6 months|24-hour diuresis, 24-hours diuresis will be assessed at day 0, at 4 weeks, 3 months and 6 months and will be classified as: * None: no change in 24- hours urinary volume * Decrease: significant (p\<0.05) reduction of 24- hours urinary volume * Increase: significant (p\<0.05) increase of 24- hours urinary volume, Day 0, 4 weeks, 3 months, 6 months|Sodium excretion in the urine, Fraction of sodium excretion will be evaluated on 24-hours diuresis at day 0, at 4 weeks, 3 months and 6 months and will be classified as: * None: no change in 24- hours sodium excretion * Decrease: significant (p\<0.05) reduction of 24- hours sodium excretion * Increase: significant (p\<0.05) increase of 24- hours sodium excretion, From day 0 to day 180|Natremia, Natremia will be evaluated on plasma samples at day 0, at 4 weeks, 3 months and 6 months and will be classified as: * None: no change in natremia * Decrease: significant (p\<0.05) reduction of natremia * Increase: significant (p\<0.05) increase of natremia, Day 0, 4 weeks, 3 months, 6 months|Mean arterial pressure, Mean arterial pressure will be evaluated according international guidelines of blood pressure assessment at day 0, at 4 weeks, 3 months and 6 months and will be classified as: * None: no change in mean arterial pressure * Decrease: significant (p\<0.05) reduction of mean arterial pressure * Increase: significant (p\<0.05) increase of mean arterial pressure, Day 0, 4 weeks, 3 months, 6 months|Glomerular filtration rate, Glomerular filtration rate will be evaluated according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) measurement at day 0, at 4 weeks, 3 months and 6 months and will be classified as: * None: no change in glomerular filtration rate * Decrease: significant (p\<0.05) reduction of glomerular filtration rate * Increase: significant (p\<0.05) increase of glomerular filtration rate, Day 0, 4 weeks, 3 months, 6 months|Child-Turcotte-Pugh (CTP) score, CTP score will be evaluated at day 0, at 4 weeks, 3 months and 6 months and will be classified as: * None: no change in glomerular filtration rate * Reduction: decrease of at least 1 point in the CTP score * Increase: increase of at least 1 point in the CTP score, Day 0, 4 weeks, 3 months, 6 months|Survival, Overall patient's survival will be evaluated after 6 months from the study enrollment, 6 months|Loop diuretics posology, Loop diuretics posology (mg/die) will be evaluated at day 0, at 4 weeks, 3 months and 6 months and will be classified as: * None: no change in loop diuretics posology to control ascites * Reduction: decrease of loop diuretics posology to control ascites * Increase: increase of loop diuretics posology to control ascites, Day 0, 4 weeks, 3 months, 6 months|Mineralocorticoid receptor antagonists posology, Mineralocorticoid receptor antagonists diuretics posology (mg/die) will be evaluated at day 0, at 4 weeks, 3 months and 6 months and will be classified as: * None: no change in mineralocorticoid receptor antagonists posology to control ascites * Reduction: decrease of mineralocorticoid receptor antagonists posology to control ascites * Increase: increase of mineralocorticoid receptor antagonists posology to control ascites, Day 0, 4 weeks, 3 months, 6 months|Metformin posology, Metformin (only in patients taking metformin) posology (mg/die) will be evaluated at day 0, at 4 weeks, 3 months and 6 months and will be classified as: * None: no change in metformin posology to control ascites * Reduction: decrease of metformin posology to control ascites * Increase: increase of metformin posology to control ascites, Day 0, 4 weeks, 3 months, 6 months|Insulin bolus posology, Insulin bolus (only in patients taking insulin) posology (mg/die) will be evaluated at day 0, at 4 weeks, 3 months and 6 months and will be classified as: * None: no change in insulin bolus posology to control ascites * Reduction: decrease of insulin bolus posology to control ascites * Increase: increase of insulin bolus posology to control ascites, Day 0, 4 weeks, 3 months, 6 months|Insulin basal posology, Insulin basal (only in patients taking insulin) posology (mg/die) will be evaluated at day 0, at 4 weeks, 3 months and 6 months and will be classified as: * None: no change in insulin basal posology to control ascites * Reduction: decrease of insulin basal posology to control ascites * Increase: increase of insulin basal posology to control ascites, Day 0, 4 weeks, 3 months, 6 months|Adverse events classification, Putative adverse events related to SGLT-2 inhibitors intake will be classified as: * Allergy: appearance of any allergic manifestation including: skin rash, itching, erythema, urticaria, angioedema, anaphylaxis, anaphylactic shock * Infectious diseases: Occurrence of any of the following conditions: Vulvovaginal candidiasis, balanitis or balanoposthitisb, urinary tract infection (including pyelonephritis and urosepsis) * Metabolism disorders: hypoglycemia, dehydration, diabetic ketoacidosis, dyslipidemia, hyperkalaemia, hyperphosphoraemia * Nervous system disorders: postural dizziness, syncope * Vascular disorders: hypotension, orthostatic hypotension * Gastrointestinal disorders: constipation, thirst, nausea * Musculoskeletal system disorders: bone fracture * Renal and urinary disorders: polyuria, pollakiuria, renal insufficiency (mainly in the context of hypovolemia), 4 weeks, 3 months, 6 months
Sponsor/Collaborators: Sponsor: University of Palermo | Collaborators: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 40
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2023-07-15
Completion Date: 2026-12-31
Results First Posted:
Last Update Posted: 2024-12-06
Locations: Internal Medicine Unit, V. Cervello Hospital, Palermo, 90100, Italy|Department of Internal Medicine, University Hospital of Palermo, Palermo, 90127, Italy
URL: https://clinicaltrials.gov/show/NCT05999773