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Could a common diabetes drug help drain dangerous belly fluid?

NCT ID NCT05999773

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Anyone

Show 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

  • Department of Internal Medicine, University Hospital of Palermo

    Palermo, Palermo, 90127, Italy

  • Internal Medicine Unit, V. Cervello Hospital

    Palermo, Italy, 90100, Italy

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