Using SGLT-2 inhibitors to treat ascites in liver cirrhosis patients
Potential Role of Sodium Glucose Cotransporter 2 Inhibitors in the Treatment of Ascites in Cirrhotic Patients
This study is testing if adding a diabetes medication called SGLT-2 inhibitors can help people with liver cirrhosis and fluid buildup feel better compared to just their usual treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Palermo Academic / other |
| Locations | 2 sites (Palermo and 1 other locations) |
| Trial ID | NCT05999773 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of SGLT-2 inhibitors, specifically glyphozines, in managing ascites in patients with liver cirrhosis and type 2 diabetes. Participants will be divided into two groups: one receiving SGLT-2 inhibitors alongside standard medical therapy, and the other continuing with standard therapy alone for six months. The study will assess both the efficacy and safety of this combined treatment approach compared to traditional methods. The focus is on patients classified as Child-Pugh A6-B9, who experience complications from ascites.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with Child-Pugh A6-B9 hepatic cirrhosis and grade 1 or 2 ascites, along with a diagnosis of type 2 diabetes.
Not a fit: Patients with advanced liver disease beyond Child-Pugh B9 or those with active alcohol use may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the management of ascites in patients with liver cirrhosis and type 2 diabetes, potentially enhancing their quality of life.
How similar studies have performed: While the use of SGLT-2 inhibitors in diabetes management is well-established, their application in treating ascites related to liver cirrhosis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Palermo and 1 other locations
- Internal Medicine Unit, V. Cervello Hospital — Palermo, Italy (Recruiting)
- Department of Internal Medicine, University Hospital of Palermo — Palermo, Italy (Recruiting)
Study contacts
- Principal investigator: Lydia Giannitrapani, MD — University of Palermo
- Study coordinator: Lydia Giannitrapani, MD
- Email: lydia.giannitrapani@unipa.it
- Phone: 00390916554710
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.