SGLT2 inhibitor: Start of SGLT-2 inhibitors to treat diabetes according diabetology indications.
Study summary
The goal of this observational study is to test the efficacy of glyphozines (SGLT-2 inhibitors) in the control of ascites in patients with liver cirrhosis in class A6-B9, according to the Child-Pugh classification, and type 2 diabetes mellitus. The investigators will compare patients belonging to the intervention group (A), who will be given SGLT-2 inhibitors according to diabetology indications in addition to standard medical therapy for 6, with patients of the control group (B), who will, instead, continue with the standard medical therapy for 6 months. Standard medical therapy will include dietary sodium restriction, treatment with diuretics (furosemide and spironolactone), hypoglycemic therapy (metformin, insulin, or both) and other supportive care.
The main questions aims of this study are:
1. Compare the efficacy and safety of a therapeutic approach based on the administration of SGLT-2 inhibitors in addition to optimal medical therapy (MRA and loop diuretic) compared to traditional diuretic therapy only, in cirrhotic patients with saline retention and diabetes.
2. Demonstrate better control of the glycemic profile in cirrhotic diabetic patients using SGLT-2 inhibitors.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Age between 18 and 80 years
* Patients diagnosed with Child-Turcotte-Pugh A6-B class Hepatic Cirrhosis (moderately impaired liver function)
* Patients diagnosed with Hepatic Cirrhosis of viral etiology (if previous hepatitis C virus (HCV) infection they must be in Sustained Virological Response (SVR); if previous hepatitis B virus (HBV) infection they must have undetectable viral genome)
* Patients diagnosed with hepatic cirrhosis of metabolic etiology
* Patients diagnosed with liver cirrhosis of alcoholic etiology (non active potus)
* Patients with grade 1 ascites: ascites detectable only ultrasound that can be fully mobilized or controlled with diuretic therapy associated with or without moderate dietary sodium restriction
* Grade 2 ascites: ascites that leads to a moderate abdominal distension and that recurs on at least 3 occasions within a 12-month period despite sodium restriction and adequate diuretic therapy (23)
* Patients diagnosed with type II diabetes mellitus defined according to 2022 American Diabetes Association (ADA) guidelines.
Exclusion Criteria:
* Inability to obtain informed consent
* Ascites of non-cirrhotic origin
* Patients diagnosed with heart failure Heart (NYHA) class =\> 2
* Patients diagnosed with acute renal failure
* Patients diagnosed with chronic renal failure and glomerular filtration rate (eGFR) below 25ml/min
* Patients with hepatocellular carcinoma (diagnosed according to the Barcelona criteria) or other active tumors (25)
* Grade 3 ascites: ascites that causes marked distention of the abdomen and that cannot be mobilized or whose early recurrence (i.e. after large volume paracentesis) cannot be satisfactorily prevented by medical therapy
* Patients diagnosed with acute Spontaneous Bacterial Peritonitis (26)
* Patients diagnosed with severe hepatic encephalopathy
* Patients diagnosed with autoimmune diseases on active steroid treatment
* Patients diagnosed with liver cirrhosis due to storage diseases
* Patients diagnosed with cirrhosis of the liver due to enzyme deficiency
* Patients diagnosed with complete portal thrombosis
* Patients with active sepsis
* Pregnant or breastfeeding women
* Patients who use drugs
* Patients with active alcohol consumption
Primary outcome measure(s)
Ascites control — Day 0, 4 weeks, 3 months, 6 months 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.
Glycemic control — Day 0, 4 weeks, 3 months, 6 months 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%
SGLT-2 inhibitors related adverse events — Day 0, 4 weeks, 3 months, 6 months 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.
Trial sites (2)
Facility
City
Region
Status
Internal Medicine Unit, V. Cervello Hospital
Palermo
Italy
Department of Internal Medicine, University Hospital of Palermo
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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