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SGLT-2 Inhibitors in the Treatment of Ascites

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v4
  2. Notable Primary completion date: Jul 15, 2024 to Jul 15, 2025
    • Study completion date: Dec 31, 2024 to Dec 31, 2026
    • Site details revised at 2 of 2 sites
    v3
  3. Notable Primary endpoints revised (3)
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 1 of 15 entries
    • Study description expanded, about 2 words
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05999773
Lead Sponsor University of Palermo
Collaborators: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Conditions
(from sponsor)
Ascites Hepatic, Cirrhosis, Liver, Diabete Type 2
Related terms Ascites, Diabetes Mellitus, Type 2, Liver Cirrhosis
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov