Could a common diabetes drug help drain dangerous belly fluid?
NCT ID NCT05999773
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether SGLT2 inhibitors, a type of diabetes medication, can help control ascites (fluid buildup in the belly) in people with liver cirrhosis and type 2 diabetes. Researchers will compare 40 patients who add the drug to their usual treatment against those who stick with standard care alone. The goal is to see if the drug improves fluid control and blood sugar levels without causing serious side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SGLT2 inhibitors (a class of diabetes drugs)
- What this could lead to
- If it works, this could point toward a new way to manage ascites (fluid buildup) in people with liver cirrhosis and diabetes, potentially reducing the need for stronger diuretics.
- What could go wrong
- This is a small observational study (40 people) with no blinding or randomization, so results may not be reliable. SGLT2 inhibitors can cause side effects like urinary infections, dehydration, or kidney issues, especially in people with liver problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
We will enroll subjects with complicated liver cirrhosis and type II diabetes mellitus consecutively, in two centers: Internal Medicine Unit of the "Policlinico Paolo Giaccone", University Hospital of Palermo, Italy and Internal Medicine Unit of the "Ospedali Riuniti Villa Sofia- Cervello" Hospital of Palermo, Italy. Patients will be assigned to intervention or control group according diabetology indications to start SGLT-2 inhibitors. Patients included in the two study groups will be sex, age and race matched.
- Ages
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18 to 80 years
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Department of Internal Medicine, University Hospital of Palermo
Palermo, Palermo, 90127, Italy
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Internal Medicine Unit, V. Cervello Hospital
Palermo, Italy, 90100, Italy
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