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NCT05999773

SGLT-2 Inhibitors in the Treatment of Ascites

Recruiting now Last updated 6 December 2024
What this trial tests

trial testing SGLT2 inhibitor in Ascites Hepatic in 40 participants. Currently enrolling.

Timeline
15 July 2023
Primary endpoint
15 July 2025
31 December 2026

Quick facts

Lead sponsorUniversity of Palermo
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment40
Start date15 July 2023
Primary completion15 July 2025
Estimated completion31 December 2026
Sites2 locations across Italy

Drugs / interventions tested

Conditions studied

Sponsor

University of Palermo

Who can join

Adults 18 to 80, any sex, with Ascites Hepatic or Cirrhosis, Liver. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of SGLT2 inhibitor

Trials testing the same drug.

Other recruiting trials for Ascites Hepatic

Currently open trials in the same condition.

Other University of Palermo trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05999773.

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