Type 2 diabetes mellitus combined with cognitive impairment
Conditions
Interventions
Trial group:Henagliflozin Proline + metformin
Control group:Metformin
Sponsors
Affiliated Hospital of Xuzhou Medical University, Xuzhou City, Jiangsu Province
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Age 45 - 75 years old 2.Patients diagnosed with T2D-MCI; 3.HbA1c 7.0% - 10.0% 4.Voluntary participation with informed consent and signature of the informed consent form. T2DM diagnostic criteria: According to the 2022 American Diabetes Association diagnostic criteria, patients with typical hyperglycemic symptoms and meeting one of the following conditions are diagnosed with diabetes: (1) Fasting plasma glucose (FPG) >= 7.0 mmol/L; (2) 2-hour plasma glucose >= 11.1 mmol/L during an oral glucose tolerance test (OGTT) after a 75-g glucose load; (3) Glycated hemoglobin (HbA1c) >= 6.5%; (4) Random plasma glucose >= 11.1 mmol/L in patients with typical symptoms of hyperglycemia or hyperglycemic crisis. If there are no typical hyperglycemic symptoms, the above indicators need to be retested, and those still meeting the criteria are diagnosed with diabetes. Fasting refers to no calorie intake for more than 8 hours, and all blood glucose levels mentioned are venous blood glucose levels. MCI diagnostic criteria:(1) Patients or informants subjectively feel a decline in cognitive function; (2) Scales indicate cognitive impairment: MoCA score 18 points.
Exclusion criteria
Exclusion criteria: 1. Patients with type 1 diabetes or other special types of diabetes; 2.Those who have used drugs that may affect cognitive function within the last three months (such as antidepressants, antipsychotics, etc.); 3. Patients with acute complications of diabetes such as diabetic ketoacidosis or hyperglycemic hyperosmolar coma, or other chronic complications; 4.Those with severe liver or kidney dysfunction; 5.Those with a history of neurological diseases such as Alzheimer's disease, dementia, or Parkinson's disease; 6.Those using other DPP-4 inhibitors or other types of GLP-1 receptor agonists.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MoCA Rating Scale Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipid levels: triglycerides (TG), total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein (HDL) Pancreatic function: fasting plasma glucose (FPG), fasting insulin (FINS), glycated hemoglobin (HbA1c);Mini-Mental State Examination (MMSE) score;Clinical Dementia Rating Scale (CDR);General information, such as age, gender, height, weight, duration of diabetes, educational level, history of hypertension, history of coronary heart disease, smoking history, and alcohol consumption history.;Other indicators: serum levels of Aß42, phosphorylated tau (p-tau181, p-tau231); HOMA-IR; inflammatory markers (e.g., IL-6, IL-1ß, TNF-a, LBP); oxidative stress markers (e.g., MDA, SOD).; | — |
Countries
China
Contacts
Public ContactYing Changjiang
Affiliated Hospital of Xuzhou Medical University, Xuzhou City, Jiangsu Province
Outcome results
None listed