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Pharmacodynamic Effects of Empagliflozin in Patients with Diabetes and Cirrhotic Ascites

Pharmacodynamic Effects of Empagliflozin in Patients with Diabetes and Cirrhotic Ascites

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119609
Enrollment
Unknown
Registered
2026-02-28
Start date
2026-03-03
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhotic Ascites

Interventions

Interventin group:On Day 1, 10mg of Empagliflozin was taken orally in the morning, and the observation continued for 4 days.

Sponsors

Baoding People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1.Age 18 years or older. 2.Body weight of at least 50 kg, with a Body Mass Index (BMI) between 18 and 35. 3.Diagnosis of decompensated liver cirrhosis with ascites. Participants must have been treated with spironolactone and furosemide in the past three months, with no dose adjustment exceeding 100% or a reduction of more than 50%. 4.Diuretic doses must have been stable for the two weeks prior to enrollment. 5.Diagnosis of Type 2 Diabetes Mellitus, with no current use of SGLT2 inhibitors. 6.Estimated Glomerular Filtration Rate (eGFR) =60 mL/min/1.73m². 7.Capable of providing independent, written informed consent.

Exclusion criteria

Exclusion criteria: Any of the following conditions will result in the exclusion of the subject from the clinical trial: 1.Systolic blood pressure less than 95 mmHg or diastolic blood pressure less than 60 mmHg. 2.History of esophageal or gastric variceal bleeding in the past 1 month. 3.Development of grade II or higher hepatic encephalopathy in the past 1 month. 4.Late-stage liver cancer. 5.Use of SGLT2 inhibitors in the past month. 6.Significant alcohol or drug abuse history in the past six months. 7.Alcohol consumption within two weeks prior to enrollment, or use of any SGLT2 inhibitors in the past three months. 8.Model for End-Stage Liver Disease (MELD) score greater than 20 or estimated median survival less than six months. 9.Hemoglobin level below 7 g/dL. 10.Use of diuretics or vasopressin receptor antagonists other than spironolactone and furosemide within two weeks prior to enrollment, such as tolvaptan or thiazide diuretics. 11.Left ventricular ejection fraction less than 40% or B-type natriuretic peptide (BNP) level greater than 1000 ng/mL in the past three months. 12.Any urinary tract infection (e.g., pyelonephritis or cystitis) in the past three months, or presence of current urinary tract infection detected during screening. 13.Currently participating in another clinical trial or study.

Design outcomes

Primary

MeasureTime frame
Sodium excretion in urine.;

Secondary

MeasureTime frame
Urinary glucose excretion;Urine volume;

Countries

China

Contacts

Public ContactRongya Shi

Baoding People's Hospital

shirongya9809@163.com+86 138 3306 2909

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026