Active — Not RecruitingNot Applicable

SGLT-2 Inhibitors in the Treatment of Ascites

Italy40 participantsStarted 2023-07-15

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 tumo…

What they're measuring

Ascites control

Timeframe: Day 0, 4 weeks, 3 months, 6 months

Glycemic control

Timeframe: Day 0, 4 weeks, 3 months, 6 months

SGLT-2 inhibitors related adverse events

Timeframe: Day 0, 4 weeks, 3 months, 6 months

Trial details

NCT IDNCT05999773

SponsorUniversity of Palermo

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-07-15

View on ClinicalTrials.gov More Ascites Hepatic trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.