Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT06147518
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-70 years
2. Child A/B Liver cirrhosis in outpatient setting
3. T2DM patients who have not used any glucose-lowering agents within 8 weeks before consenting, or those who have only used metformin, in addition to diet and exercise
4. HbA1c level of 7.1% or higher but no more than 9.0%
5. BMI of 23 kg/m2 or higher
6. patients who can be monitored closely for medication compliance
7. patients who provide written informed consent.
Exclusion Criteria:
1. Age \<18 years
2. Post renal or liver transplantation
3. CTP C / ACLF
4. Intrinsic/structural kidney disease, obstructive uropathy, ADPKD, Anatomic urologic defects that predispose to urinary tract infection
5. Active sepsis / SBP at enrollment
6. Grade II/III/IV HE
7. Pregnancy or Lactating mother
8. Known CKD, obstructive uropathy
9. Patient on MV, NIV, systemic sepsis and shock
10. Lack of informed consent
11. Prior intolerance or S/E to SGLT-2i or DPP4i
12. patients with type 1 diabetes or secondary diabetes
13. patients with medical history of diabetic ketoacidosis
14. patients with medical history of myocardial infarction, cerebral infarction, or stroke within 12 weeks before consent to the study
15. estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m2
16. unstable hypertension or dyslipidemia within 12 weeks before consent to the study
17. HB \<9 g/L, patients with haemoglobinopathy, acute hemolysisStudy period: one year after ethical approval.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06147518
Study Brief:
Protocol Section:
NCT06147518