SGLT-2 Inhibitors in the Treatment of Ascites

Launched by UNIVERSITY OF PALERMO · Aug 11, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a type of medication called SGLT-2 inhibitors on patients with ascites, which is fluid buildup in the abdomen, often due to liver cirrhosis and type 2 diabetes. The study will compare two groups of participants: one group will receive SGLT-2 inhibitors along with their usual treatments, while the other group will continue with their standard care without the new medication. The goal is to see if adding SGLT-2 inhibitors helps control the fluid buildup better and improves blood sugar levels in patients with liver issues and diabetes.

To be eligible for this trial, participants should be between 18 and 80 years old, have moderate liver cirrhosis, and have type 2 diabetes. They should also have mild to moderate fluid buildup in their abdomen that can be treated with medications. Participants will be monitored for six months and can expect to continue their regular treatment while possibly receiving the new medication. It’s important to note that certain conditions, such as severe heart or kidney problems, active liver cancer, or ongoing drug or alcohol use, would exclude someone from participating in this trial.

Gender

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Eligibility criteria

• 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