Diabetes
Conditions
Interventions
Sponsors
Department of Endocrinology and Metabolism, Zhujiang Hospital, Southern Medical University
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects included in the study should meet the following criteria: 1) Newly diagnosed with type 2 diabetes without oral hypoglycemic agents or insulin therapy; 2) Men and women are eligible at the age of 20-65 years old; 3) 7.0% = glycated hemoglobin level (HbA1) =9.0%; 4) 24kg/m2=BMI=35kg/m2; 5) Voluntary participation and cooperation research and signed informed consent.
Exclusion criteria
Exclusion criteria: The subject may should not be included in this study if any of the following exclusion criteria are met: 1. Patients with severe diabetic complications such as diabetic ketoacidosis, hyperosmolar hyperglycemia syndrome, lactic acidosis; 2. Patients with clinically significant hepatobiliary disorders, including but not limited to chronic active hepatitis and/or severe liver dysfunction, cirrhosis. ALT or AST>3 times the normal upper limit (ULN) or serum total bilirubin (TB)>34.2µmol/L(>2 mg/dL); 3. Patients with the following nephrotic history or kidney disease-related characteristics: 1) History of unstable or acute kidney disease; 2) Patients with moderate/severe renal injury or end-stage renal disease (eGFR 1800 mg/g; 4) Serum creatinine (Cr)=133µmol/L (=150mg/dL) in male subjects; the serum Cr=124µmol/L(>1.40mg/dL) in female subjects; 4.Any of the following cardiovascular diseases occured in the last 6 months: 1) Myocardial infarction; 2) cerebral infarction; 3) Cardiac surgery or revascularization (coronary artery bypass surgery/percutaneous transluminal coronary angioplasty); 4) Unstable angina; 5) Congestive heart failure (New York Heart Society grade III or IV); 6) Transient ischemic attack or significant cerebrovascular disease; 5. Patients with severe digestive diseases that may cause severe constipation, chronic or acute diarrhea; 6. Eat yogurt in the past 1 week, receive antibiotics in the past 30 days; 7. Pregnant women or women who plan to become pregnant during the study period, women who are currently lactating or who do not adopt effective, medically recognized birth control methods; 8. Combined with malignant tumors, multiple organ dysfunction and other chronic wasting diseases; 9. Those who have undergone gastrointestinal or other abdominal surgery within one year, such as weight loss surgery; 10. At the discretion of the investigator, it is not possible to follow the subjects of the protocol, patients with severe physical or mental illnesses that may affect effectiveness or safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycated Hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycosylated serum albumin;Weight;Glucose Metabolism Index;Serum Lipid;Liver Function;Renal Function;flora; | — |
Countries
China
Contacts
Public ContactHong Chong
Department of Endocrinology and Metabolism, Zhujiang Hospital, Southern Medical University
Outcome results
None listed