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A multicenter study on the effects and safety of proline combined with empagliflozin tablets on blood lipids in patients with abdominal obesity and type 2 diabetes

A multicenter study on the effects and safety of proline combined with empagliflozin tablets on blood lipids in patients with abdominal obesity and type 2 diabetes

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500111560
Enrollment
Unknown
Registered
2025-11-03
Start date
2025-11-07
Completion date
Unknown
Last updated
2025-11-11

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

Conditions

Abdominal obesity type 2 diabetes

Interventions

Proline combined with Gliclazide treatment group:NA

Sponsors

Shougang Shuigang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-70 years, regardless of gender; 2. Clinically diagnosed with type 2 diabetes (referencing the "Chinese Guidelines for the Prevention and Treatment of Diabetes (2024 Edition)"); 3. BMI >=24 kg/m²; 4. Assessed by a physician as suitable for treatment with proline plus glimepiride tablets; 5. Voluntarily participating in the study and signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Moderate to severe renal impairment (eGFR =160 mmHg or diastolic BP >=100 mmHg); 3. Impaired liver function: ALT or AST >=3 times the upper limit of normal; 4. Acute or chronic metabolic acidosis, including diabetic ketoacidosis; 5. History of severe allergy to dapagliflozin, any excipient of this product, or any other SGLT-2 inhibitor; 6. Currently participating in, or has participated in, any other clinical trial within the past month; 7. Deemed unsuitable for participation in this study by the investigator.

Design outcomes

Primary

MeasureTime frame
Triglycerides;

Secondary

MeasureTime frame
Glycated hemoglobin;Total cholesterol;High-density lipoprotein cholesterol;Low-density lipoprotein cholesterol;Fasting Blood Glucose;Blood sugar 2 hour after a meal;Body Mass Index;Alanine aminotransferase;Aspartate aminotransferase;Blood urea;Blood Creatinine;Blood uric acid;

Countries

China

Contacts

Public ContactMin Zhang

Shougang Shuigang Hospital

1060676456@qq.com+86 158 8505 6913

Outcome results

None listed

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