Type 2 Diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1)Diagnosis of T2DM conforms to the clinical diagnostic criteria of the American Diabetes Association; 2) aMCI meets the diagnostic criteria for aMCI as defined by Peterson; 3) Age between 60 and 80 years; 4) MoCA score <26 points, Clinical Dementia Rating Scale score =0.5, Hachinski Ischemia Score =4 points; 5) Agree to participate in this study and sign the informed consent form. Patients are conscious and able to cooperate with examinations, questionnaires, and medical history collection, either independently or with the assistance of family members.
Exclusion criteria
Exclusion criteria: Exclusion criteria: Individuals with cognitive normality or severe cognitive impairment affecting written and verbal communication; 2) Individuals with severe aphasia or dysarthria; 3) Individuals with neurological and psychiatric diseases (e.g., degenerative and/or vascular dementia, Parkinson's disease, stroke, and severe depression) or severe multi-organ diseases (e.g., anemia, pulmonary diseases, cancer) that impact cognitive function; 4) Individuals with other severe somatic diseases or severe abnormalities in thyroid, liver, or kidney function; 5) Individuals requiring long-term immunosuppressive therapy or those who have taken antibiotics within one month prior to enrollment or during follow-up; 6) Individuals who discontinue or arbitrarily adjust the investigational product during follow-up; 7) Individuals who concurrently take bowel-promoting medications, such as polyethylene glycol electrolyte, phenolphthalein tablets, or senna leaves, during follow-up; 8) Individuals with chronic digestive system diseases or tumors, such as peptic ulcers, inflammatory bowel disease, or severe liver disease; 9) Individuals allergic to the investigational product or experiencing significant digestive symptoms, such as intolerance; 10) Individuals with irregular or significantly changed dietary habits during follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mini-Mental State Examination;Montreal Cognitive Assessment Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Depression Scale;Pittsburgh Sleep Quality Index (PSQI);blood lipids;Fasting Blood Glucose;glycated hemoglobin;Constipated Patients' Quality of Life Scale;Urinary microalbumin;C-peptide;Protein/Creatinine Ratio;C-reactive protein;Total Bilirubin;Albumin;Uric acid;creatinine;Urea;Complement C1q;Glutamic-oxaloacetic transaminase;Alanine Aminotransferase;Gamma-glutamyl transferase;Interleukin-6; | — |
Countries
China
Contacts
Weihai Municipal Hospital