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SGLT-2 Inhibitors in the Treatment of Ascites

NCT05999773 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

  • Ascites Hepatic
  • Cirrhosis, Liver
  • Diabete Type 2

Interventions

DRUG

SGLT2 inhibitor

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

Sponsors & Collaborators

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

    collaborator OTHER

  • University of Palermo

    lead OTHER

Principal Investigators

  • Lydia Giannitrapani, MD · University of Palermo

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-15
Primary Completion
2025-07-15
Completion
2026-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05999773 on ClinicalTrials.gov