type 2 diabetes
Conditions
Sponsors
the first affiliated hospital of harbin medical university
Eligibility
Sex/Gender
All
Age
25 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) be able to complete the research according to the requirements of the test plan; 2) Meet the diagnostic criteria of WHO World Health Organization T2DM(2019), aged 25-65 years; Gender is not limited; BMI:19.0-35.0kg/m2; 3) Patients who took diet, exercise, stable dose of metformin, sulfonylurea oral hypoglycemic agents (SUs) or insulin as the treatment route to lower their blood sugar at least 3 months before the start of the study; 4) HbA1c at screening: 6.5%-10.0%, fasting blood glucose: 7.0-13.3 mmol/L; Sign the informed consent before the test, and fully understand the content, process and possible adverse reactions of the test.
Exclusion criteria
Exclusion criteria: 1) type 1 diabetes; 2) Smoking, alcoholism and autoimmune diseases; 3) Treatment except antidiabetic drugs mentioned in the standard (pioglitazone, GLP-1 analogues, DPP IV inhibitors, etc.); 4) Have taken antimicrobial agents, probiotic preparations or drugs that inhibit gastric acid or gastrointestinal motility in the past 6 weeks; 5) Complicated with diseases such as 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 test drug; 7) Cases with clinical significance judged by researchers, including physical examination, vital signs examination and clinical laboratory examination; 8) Female subjects are breast-feeding or have positive pregnancy test results during the screening period or during the trial; 9) Drugs affecting intestinal flora (including antibacterial drugs, microecological agents, intestinal mucosal protective agents, Chinese patent medicines, etc.) were used continuously for more than one week within one month before screening; 10) Stop taking the test sample or take other drugs halfway, and it is impossible to judge the efficacy or incomplete information; 11) taking items with similar functions to the subjects in a short period of time, which affects the judgment of the results; 12) Subjects cannot participate in the experiment due to their own reasons; 13) Subjects judged unsuitable by other researchers. 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; | — |
Countries
China
Contacts
Public ContactLili Shi
the first affiliated hospital of harbin medical university
Outcome results
None listed