type 2 diabetes
Conditions
Interventions
experimental group:oral Bifidobacterium BLa80
Sponsors
the first affiliated hospital of harbin medical university
Eligibility
Sex/Gender
All
Age
25 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Able to complete research according to the requirements of the experimental protocol; 2) Meets the WHO T2DM (2019) diagnostic criteria, aged 25-65 years; Gender unlimited; BMI: 19.0-35.0kg/m2; 3) At least 3 months before the start of the study, patients who simply take diet, exercise, Metformin, sulfonylurea oral hypoglycemic agents (SUs) or insulin as a treatment to reduce blood sugar; 4) At screening, HbA1c: 6.5% -10.0%, Glucose test#Fasting blood sugar: 7.0-13.3 mmol/L; 5. Before the experiment, sign an informed consent form and have a thorough understanding of the experiment content, process, and potential adverse reactions.
Exclusion criteria
Exclusion criteria: 1) Type 1 diabetes; 2) Smoking, alcoholism, and autoimmune diseases; 3) Treatment other than anti diabetes drugs (Pioglitazone, GLP-1 analogues, DPP IV inhibitors, etc.) mentioned in the inclusion criteria; 4) Have taken Antimicrobial, probiotics or drugs that inhibit gastric acid or gastrointestinal motility in the past 6 weeks; 5) Complicated with hypertension, coronary heart disease, diabetes, chronic liver disease, kidney disease or tumor or chronic infection; 6) Participated in other drug clinical trials within 3 months before taking the investigational drug; 7) Cases that have been judged by researchers to be clinically significant, including physical examination, vital sign examination, and clinical laboratory examination; 8) Female subjects are currently breastfeeding or have positive pregnancy test results during the screening period or trial process; 9) Drugs that affect Gut microbiota (including antibacterial drugs, probiotics, intestinal mucosal protective agents, traditional Chinese patent medicines and simple preparations, etc.) are continuously used for more than one week within one month before screening; 10) Those who stop taking the test sample or add other drugs midway, and cannot determine the efficacy or have incomplete information; 11) Taking items with similar functions to the test subjects in the short term can affect the judgment of the results; 12) Subjects who are unable to participate in the experiment due to their own reasons; 13) Subjects deemed unsuitable by other researchers to participate. Those who meet any of the above conditions shall not be selected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood biochemistry;glycosylated hemoglobin; intestinal flora sequencing; | — |
Secondary
| Measure | Time frame |
|---|---|
| fasting blood-glucose;Blood lipid levels;uric acid; | — |
Countries
China
Contacts
Public ContactLili Shi
the first affiliated hospital of harbin medical university
Outcome results
None listed