T2DM
Conditions
Interventions
Group A:Bifidobacterium M8
Group B:Placebo
Sponsors
Weihai Municipal Hospital
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 45-80 years old. 2. Patients with prediabetes or recently diagnosed type 2 diabetes. The diagnosis of prediabetes meets the American Diabetes Association guidelines as: (i) fasting blood glucose levels between 5.6 mmol/L and 6.9 mmol/L, or; (ii) blood glucose level between 7.8 mmol/L and 11 mmol/L two hours after a meal (oral glucose tolerance test), or; (iii) glycosylated hemoglobin between 5.7% and 6.4%. Diagnostic criteria for type 2 diabetes are based on American Diabetes Association guidelines. Patients with recently diagnosed type 2 diabetes who are required to have been diagnosed with type 2 diabetes by an endocrinologist within the past 12 months should be diagnosed with one of the following: (i) fasting blood glucose level >=7.0 mmol/l; (ii) blood glucose level 2 hours after challenge (oral glucose tolerance test) >=11.1 mmol/l or; (iii)HbA1c>=6.5%. 3. Complaints of memory impairment (within 6 months). 4. The patient is conscious and able to complete the examination operation, questionnaire survey, medical history collection, etc. by himself or with the help of his family. 5. Agree to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes 2. Diagnosed with type 2 diabetes mellitus more than 12 months ago. 3. Taking anti-obesity drugs or hypoglycemic drugs other than metformin (i.e., sulfonylureas, a-glucosidase inhibitors, thiazolidinediones, and glucagon-like peptide-1 analogues). 4. Alzheimer's disease or other dementia (MMSE is used to exclude patients with dementia: for illiterate, MMSE score is less than 17; For participants with primary education, the MMSE was less than 20; MMSE less than 24 for participants with junior high school education or above), severe psychiatric or neurological illness (e.g., major depressive disorder, schizophrenia, Parkinson's disease, Huntington's disease), alcohol or substance abuse, or participants with a history of head trauma or systemic disease affecting brain function (e.g., systemic lupus erythematosus, congestive heart failure). 5. Concomitant gastrointestinal disorders (i.e., irritable bowel syndrome, inflammatory bowel disease, and celiac disease) 6. Recent (within the past 4 weeks) use of antibiotics and dietary supplements (fish oil, probiotics, prebiotics, multivitamins, minerals, nutraceuticals, and herbal preparations) 7. Pregnant, breastfeeding, or planning to become pregnant 8. Active infection or clinical evidence of any other serious illness. 9. Those who are allergic to the test sample or have obvious digestive symptoms, such as intolerance; 10. Patients with irregular eating habits and large changes during the follow-up period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting and 2 hours postprandial blood glucose, glycated hemoglobin, fasting C-peptide and insulin levels;Insulin resistance index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive function;Anxious;Depression;Sleep;Constipation; | — |
Countries
China
Contacts
Public ContactZhang Jinbiao
Weihai Municipal Hospital
Outcome results
None listed