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RECRUITING

NCT05999773

SGLT-2 Inhibitors in the Treatment of Ascites

Sponsor: University of Palermo

View on ClinicalTrials.gov

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.

Official title: Potential Role of Sodium Glucose Cotransporter 2 Inhibitors in the Treatment of Ascites in Cirrhotic Patients

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

Start Date

2023-07-15

Completion Date

2026-12-31

Last Updated

2024-12-06

Healthy Volunteers

Not specified

Conditions

Ascites Hepatic Cirrhosis, Liver Diabete Type 2

Interventions

DRUG

SGLT2 inhibitor

Start of SGLT-2 inhibitors to treat diabetes according diabetology indications.

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

Locations (2)

Internal Medicine Unit, V. Cervello Hospital

Palermo, Italy, Italy

Department of Internal Medicine, University Hospital of Palermo

Palermo, Palermo, Italy