Type 2 diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Chinese Han patients with T2DM will be recruited; aged 35-70 years; 6.5% = HbA1c = 12.0%; BMI<28kg/m2;
Exclusion criteria
Exclusion criteria: (1) type 1 diabetes; pregnancy; lactation; an intent to become pregnant during the course of the study; (2) severe diabetic complications (diabetic retinopathy, diabetic neuropathy, diabetic nephropathy and diabetic foot); (3) severe hepatic diseases (including chronic persistent hepatitis, liver cirrhosis or the co-occurrence of positive hepatitis B virus surface antigen and abnormal hepatic transaminase (serum concentrations of alanine transaminase or aspartate transaminase >2.5× the upper normal limit)); (4) continuous antibiotic use for >3 days within 3 months prior to enrolment; (5) continuous use of weight-loss drug for>1month; (6) gastrointestinal surgery (except for appendicitis or hernia surgery); (7) severe mental illness within 6 months prior to enrolment; (8) receiving drug therapy to treat cholecystitis, peptic ulcers, urinary tract infection, acute pyelonephritis, urocystitis or hyperthyreosis; (9) pituitary dysfunction;secondary diabetes mellitus; (10) severe organic diseases, including cancer,coronary heart disease, myocardial infarction or cerebral apoplexy; (11) infectious diseases, including pulmonary tuberculosis and AIDS; (12) alcoholism; (13) Other conditions may affect gut microbiota (drugs, foods, diseases, and so on).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood glucose;HbA1C;gut microbiota;short chain fatty acid; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood chemistry for liver function;Blood chemistry for kidney function;Total Cholesterol;Triglyceride;Albumin creatinine ratio; | — |
Countries
China
Contacts
The Affiliated Hospital of XiangNan University