Type 2 diabetes mellitus combined with mild cognitive impairment
Conditions
Interventions
Experimental group:Proline combined with empagliflozin background therapy
Control group:Background treatment
Sponsors
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
55 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 55–80 years (inclusive), no gender restriction; 2. Meet the diagnostic criteria for type 2 diabetes (refer to "Chinese Guidelines for Diabetes Prevention and Treatment (2024 Edition)"); 3. At screening, local laboratory test HbA1c >=6.5% and =6 years; 7. Voluntarily willing to participate in this study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Individuals with type 1 diabetes or other specific types of diabetes; 2. Individuals who have experienced more than two episodes of diabetic ketoacidosis or hyperosmolar hyperglycemic state requiring hospitalization within 6 months prior to screening; 3. Individuals with uncontrolled or poorly managed hypertension at the time of screening (systolic BP >=160 mmHg and/or diastolic BP >=100 mmHg) or hypotension (systolic BP 3 times the upper limit of normal, or total bilirubin (TBIL) >2 times the upper limit of normal; 10. Individuals with a history of malignant tumors within 5 years prior to screening (exceptions: cured skin squamous cell carcinoma, basal cell carcinoma, and cervical carcinoma in situ, or malignant tumors deemed cured with minimal risk of recurrence by the investigator); 11. Individuals with severe kidney stones (causing serious complications such as urinary tract obstruction, renal failure, uremia, etc.) or a history of severe recurrent kidney stones at the time of screening; 12. Individuals with systemic reactions such as fever due to genitourinary infection at the time of screening or those who had repeated (>3 times) genitourinary infections in the 12 weeks prior to screening; 13. Individuals with a history of positive HIV antibodies; 14. Individuals with an eGFR <60 mL/min/1.73 m^2 as calculated by the CKD-EPI formula at screening, or those with unstable or rapidly progressing kidney disease; 15. Individuals who underwent major surgery within 12 weeks prior to screening or have not yet fully recovered from surgery; 16. Individuals who used SGLT-2 inhibitors or GLP-1 receptor agonists within 8 weeks prior to screening, or who previously used SGLT-2 inhibitors but discontinued due to poor efficacy or intolerance to adverse reactions; 17. Individuals who took medications that improve cognition (such as cholinesterase inhibitors, amino acid receptor antagonists, etc.) within 12 weeks prior to screening; 18. Individuals with known allergies to the active ingredient or excipients of proline-containing dapagliflozin tablets, or a history of allergy to SGLT-2 inhibitors; 19. Individuals who participated in another drug clinical trial within the 3 months prior to screening; 20. W
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MoCA Rating Scale Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood test (GLUHbA1cINSC-PC-reactive proteinASTALTTotal cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol);Brain functional magnetic resonance imaging;Mini-Mental State Examination (MMSE) score;Vital signs and anthropometric measurements; | — |
Countries
China
Contacts
Public ContactJiaqiang Zhou
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Outcome results
None listed