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Real-world study of the protective and renal efficacy of proline plus gliflozin in the treatment of adults with type 2 diabetes mellitus and early renal ultrafiltration damage (A post-marketing registry cohort study based on the Anhui cohort of diabetic nephropathy)

Real-world study of the protective and renal efficacy of proline plus gliflozin in the treatment of adults with type 2 diabetes mellitus and early renal ultrafiltration damage (A post-marketing registry cohort study based on the Anhui cohort of diabetic nephropathy)

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114340
Enrollment
Unknown
Registered
2025-12-10
Start date
2025-12-15
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Diabetic nephropathy

Interventions

Research Group:None

Sponsors

The First Affiliated Hospital of Wannan Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged over 18 years and under 85 years; 2. Patients meeting the WHO (2005) diagnostic criteria for diabetes mellitus: (1) Presence of diabetes symptoms with venous plasma glucose concentration >=11.1 mmol/L at any time point. (2) Fasting venous plasma glucose concentration >=7.0 mmol/L. (3) Oral glucose tolerance test (OGTT): venous plasma glucose concentration >=11.1 mmol/L two hours after oral administration of 75 g glucose. Diagnosis of diabetes mellitus is confirmed if any one of the above three criteria is met, and any subsequent repeat test of any one of these three criteria within the following day also meets the criteria. 3. Patients with renal ultrafiltration exceeding 120 mL/min/1.73 m² (eGFR) 4. HbA1c (glycated haemoglobin) >=6% and <12% 5. Signed informed consent form.

Exclusion criteria

Exclusion criteria: Exclude subjects meeting any of the following criteria: 1. Patients currently using SGLT2 inhibitors or SGLT2 inhibitor combination therapies; 2. Type 1 diabetes mellitus; 3. Acute diabetic complications (diabetic ketoacidosis, hyperosmolar diabetic state); 4. Acute clinical cardiovascular events (acute coronary syndrome, prior percutaneous coronary intervention) or hospitalisation for unstable angina within the past 3 months; symptomatic heart failure (NYHA Class IV) within the past 6 months; 5. Hospitalisation within the past 6 months due to extensive cerebral infarction or haemorrhage, presenting with impaired consciousness, hemiplegia, and dysarthria; 6. Symptomatic heart failure within the past 6 months (NYHA Class IV); 7. Expected survival of less than 5 years; 8. Acute infection, trauma, surgery, or other stress states; 9. Concurrent malignant neoplasms; 10. Pregnant or lactating women; 11. Any condition judged by the study physician to compromise study compliance; 12. Failure to sign the written informed consent form; 13. Current participation in another interventional study.

Design outcomes

Primary

MeasureTime frame
Glomerular filtration rate;blood glucose;

Secondary

MeasureTime frame
Glycated hemoglobin;

Countries

China

Contacts

Public ContactJialin Gao

The First Affiliated Hospital of Wannan Medical College

gaojialin@wnmc.edu.cn+86 183 5533 5266

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026