RecruitingNCT05999773

SGLT-2 Inhibitors in the Treatment of Ascites

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


Sponsor

University of Palermo

Enrollment

40 participants

Start Date

Jul 15, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether SGLT-2 inhibitors (a class of diabetes/kidney drugs such as empagliflozin or dapagliflozin) can reduce the build-up of fluid in the abdomen (ascites) in patients with liver cirrhosis. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with liver cirrhosis from viral hepatitis (hepatitis B or C), metabolic liver disease, or alcohol-related liver disease (provided you have stopped drinking) - Your liver function is moderately impaired (Child-Turcotte-Pugh class A6-B) - You have ascites (fluid in the abdomen) — either detectable only on ultrasound or causing visible abdominal swelling **You may NOT be eligible if...** - You have hepatitis C that has not achieved a sustained virological response (SVR), or hepatitis B with detectable viral levels - Your liver function is severely impaired (Child-Pugh class C) - You are still actively drinking alcohol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSGLT2 inhibitor

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


Locations(2)

Internal Medicine Unit, V. Cervello Hospital

Palermo, Italy, Italy

Department of Internal Medicine, University Hospital of Palermo

Palermo, Palermo, Italy

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NCT05999773


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