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NCT05999773
SGLT-2 Inhibitors in the Treatment of Ascites
trial testing SGLT2 inhibitor in Ascites Hepatic in 40 participants. Currently enrolling.
15 July 2025
Quick facts
| Lead sponsor | University of Palermo |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 40 |
| Start date | 15 July 2023 |
| Primary completion | 15 July 2025 |
| Estimated completion | 31 December 2026 |
| Sites | 2 locations across Italy |
Drugs / interventions tested
- SGLT2 inhibitor — full drug profile →
Conditions studied
- Ascites Hepatic — all drugs for Ascites Hepatic →
- Cirrhosis, Liver — all drugs for Cirrhosis, Liver →
- Diabete Type 2 — all drugs for Diabete Type 2 →
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.
Verify or expand the search:
- PubMed search for NCT05999773
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05999773 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Palermo
- Last refreshed: 6 December 2024
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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