Type 2 diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.It meets the WHO standard for diagnosis and treatment of type 2 diabetes in 1999; 2.The duration of the disease does not exceed 5 years; 3.Body Mass index (BMI) >=24 kg/m2; 4.Age 18-70 years old; 5.Hemoglobin A1C >=6.5%;
Exclusion criteria
Exclusion criteria: 1.Type 1 diabetes and specific type diabetes were excluded; 2.Patients who received thiazolidinediones, GIP/GLP-1RA, glucosidase inhibitors or DPP-IV enzyme inhibitors, GKA and other hypoglycemic agents within 2 weeks prior to enrollment; 3.Use of antibiotics or probiotic supplements within 3 months prior to enrollment or during the study; 4.Acute or chronic digestive diseases or related medications (including diarrhea, gastrointestinal infections, cholecystitis, digestive tract obstruction, etc.); Gastrectomy, fundus folding, colostomy and other digestive system surgery; 5.In recent 3 months, the weight fluctuation was > 5%; Diseases that may affect absorption, metabolism, and weight (e.g. Cushing, hyperthyroidism, hypothyroidism, etc.); 6.Patients with moderate or severe renal impairment (serum creatinine > 2mg/dL or 177mmol/L), or abnormal liver function (ALT>2 times the upper limit of normal); Moderate to severe chronic obstructive pulmonary disease; Patients with severe hypertension, cerebrovascular accident and tumor; 7.People with a history of severe drug allergy, asthma, hives or other allergies; 8.Pregnant and lactating women; 9.People with active infectious diseases such as tuberculosis, hepatitis and AIDS; 10.Patients with severe and acute complications of diabetes, such as diabetic ketoacidosis, lactic acidosis, diabetic hyperosmolar state, diabetic foot, and severe chronic complications; 11.Subjects receiving controlled medications, including antidepressants, antiserotonin, barbiturates, antipsychotics, and central nervous system stimulants; 12.Patients with poor compliance or difficulty in completing treatment; 13.Sufficient time to participate in this project cannot be guaranteed; 14.Other researchers were assessed not to be suitable for participation in the project;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| Oral glucose tolerance test(OGTT), Insulin release test, C-peptide release test, Blood lipid, Dynamic blood glucose test, Time in range(TIR) of glucose;Height, weight, body mass index(BMI), waist circumference, hip circumference, body composition analysis;Composition and function of fecal flora;Vital signs monitoring, blood routine, urine routine, liver function, kidney function, electrocardiogram; | — |
Countries
China
Contacts
Henan Provincial People's Hospital