diabetes
Conditions
Interventions
Group 1:hypoglycemic treatment + probiotics
Group 2:Maintain the original hypoglycemic treatment
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 68 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with type 2 diabetes according to WHO classification or other locally applicable diagnostic criteria; 2. Age between 18-68 years; 3. As determined by the central laboratory at visit 1, HbA1c >= 6.5% and <= 9%; 4. Received stable diabetes medication and/or insulin therapy within at least 2 months before visit 1 and between visit 1 and visit 3; 5. The patient agrees not to start a diet and/or exercise program aimed at weight loss during the study period, in addition to the lifestyle and dietary measures of conventional diabetes treatment; 6. Reliable contraceptive methods; female patients of childbearing age: negative serum pregnancy test results at visit 1; contraceptive measures can be effectively implemented during the experiment; 7. In the opinion of the researcher, have good motivation, ability and willingness to: (1) Perform fingertip blood glucose monitoring, including up to 7 planned blood glucose measurements within 1 day; (2) According to the requirements of this research plan, maintain the research log; 8. Sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Treatment with antibiotics, live microbial preparations, lactulose, dietary supplements or traditional Chinese medicines within the past 3 months; 2. Unstable weight in the past 3 months; 3. Subjects are receiving low-carbohydrate diet (such as: Atkins diet) treatment; 4. Suffering from type 1 diabetes, adult latent autoimmune diabetes, secondary diabetes, malignant tumor, cardiovascular disease, gastrointestinal disease, respiratory system disease, liver and kidney insufficiency, thyroid-related disease, acute infection, allergy physical constitution, moderate or severe liver and kidney damage, history of surgery or trauma within the past 6 months, periodontal disease, autoimmune disease, and other endocrine system-related diseases retinopathy, diabetic retinopathy, or peripheral vascular disease; 5. Severe psychological disorder or consciousness disorder, which is not convenient for communication; 6. Pregnant, lactating women or women with pregnancy plans; 7. Smoking and drinking; 8. Has participated in other clinical trials, etc.; 9. Participate in another clinical study within 6 months before the start of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycated hemoglobin; | — |
Countries
China
Contacts
Public ContactChen Haibing
Shanghai Tenth People's Hospital
Outcome results
None listed