Type 2 diabetes and mild cognitive impairment
Conditions
Interventions
Hengpagliflozin treatment group:On the basis of the original treatment plan, the SGLT2 inhibitor proline and constantagliflozin tablets were added
placebo group:Adding a placebo to the original treatment plan
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all the following inclusion criteria: 1) Voluntarily participate in this study, be able to cooperate in completing cognitive function assessment and sign informed consent; 2) Aged 50 to 80 years old, both men and women are welcome; 3) T2DM complies with the 1999 World Health Organization WHO diabetes diagnostic criteria; 4) The diagnosis of MCI patients meets the main clinical criteria for MCI proposed by the National Institute on Aging and the AD Association; 5) The patient has not used SGLT2 inhibitor drugs in the past; 6) There is no clear and extensive cerebral infarction History of cerebral white matter demyelination; 7) 7.5% = glycated hemoglobin HbA1c = 10.0%; 8) Fasting plasma glucose (FPG) = 11.1mmol/L; 9) 19<BMI = 36.0kg/m2.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following conditions will not be included in the study: 1) Previously diagnosed with dementia, stroke, Parkinson's, multiple sclerosis, mental illness and other diseases that affect cognitive function; 2) Type 1 diabetes and severe diabetes Target organ complications (diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic syndrome (HHS), diabetic foot), single gene mutation diabetes, diabetes due to pancreatic damage, or other secondary diabetes (such as Cushing's syndrome) symptoms or diabetes caused by acromegaly); 3) Have a history of severe hypoglycemia (such as hypoglycemia causing drowsiness, impaired consciousness, delirium, or even coma, requiring the assistance of others to treat hypoglycemia), or repeated hypoglycemia [ Symptomatic hypoglycemia occurs =3 times within a week, or blood glucose levels are detected at least 3 times within a week]; 4) Severe complications such as cardiac insufficiency, liver insufficiency, renal insufficiency, severe renal damage, end-stage renal disease, or the need for dialysis Systemic diseases; 5) Patients with combined blood and immune system diseases, chronic infections, and mental illness, especially those who need to take hormones; 6) Those with a history of malignant tumors in the 5 years before screening, excluding treated local skin basal cell carcinoma; 7) Before screening Patients who have been addicted to alcohol, drugs, and psychotropic drugs for 3 months; 8) Patients with diabetes insipidus, or patients with thyroid dysfunction whose therapeutic dose has not been stable within 3 months before screening; 9) Patients with frequent urinary tract infections (=3 times/year); 10) People who are known to be allergic to any study drugs or excipients; 11) Contraindications to MRI scanning: claustrophobia, metal implants in the body, etc. 12) Participated in other drug clinical studies within 4 weeks before the first study treatment; 13) Other factors that the researcher believes are not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serological indicators related to cognitive function;MRI scan of the brain;Montreal Cognitive Assessment (MoCA);Mini-Mental State Evaluation (MMSE) scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glucose metabolism indicators; | — |
Countries
china
Contacts
Public Contactweiming chen
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed