Type 2 Diabetes
Conditions
Interventions
Sponsors
Ruijin hospital affiliated to Jiaotong University Medical School
Eligibility
Sex/Gender
All
Age
20 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1)New onset Type 2 Diabetes, both men and women; (2)During the screening period, 7%= HbA1c (glycosylated hemoglobin A1c) <11%, and 7.0mmol/L= FBG (fasting blood glucose concentration) =13.3mmol/L on the day of screening; (3)Age between 20-70 years old; (4)BMI (body mass index) between19.0~33.0kg/m2; (5)Without any previous drug treatment to control blood glucose; (6)Only use lifestyle intervention (diet and exercise) to control blood glucose for at least 2 months before the screening period; (7)Prior to the study, understand the nature, significance, possible benefits, inconvenience and potential dangers of the study in detail; (8)Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted
Exclusion criteria
Exclusion criteria: (1)Having severe hepatic and renal failure (ALT>=2.5 fold higher than the normal range, Cr>=132µmol/L, eGFR <60 mL/min/1.73m2), Psychiatric disorders, severe infectious diseases, severe anaemia, severe neutropenia; (2)Had severe cardiac diseases, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, New York Heart Association (NYHA) cardiac function evaluation =? degree; (3)Had type 1 diabetes, single-gene mutation diabetes, diabetes caused by pancreatic injury, or other secondary diabetes (such as diabetes caused by Cushing's syndrome, abnormal thyroid function, or acromegaly); (4)Had acute diabetic ketonuria acidosis and hyperosmotic coma within 3 months; (5)Have used oral antidiabetic medicines or insulin or incretin drugs to control diabetes; (6)Have taken antibiotics within 3 months; (7)Have used weight control drugs (including weight-loss drugs), corticosteroids and other hormone drugs by oral, intramuscular, intravenous systemic, parenteral or intra-articular administration within 3 months; (8)Pregnancy; (9)Have been enrolled in other clinical trials within 3 months; (10)Had organ system tumors (except local skin basal cell carcinoma) that have been treated or not treated within 5 years, regardless of whether there is evidence of local recurrence or metastasis; (11)Have a history of active substance abuse, including alcohol and a history of alcohol-related illnesses within 2 years; (12)Having severe digestive diseases that might cause severe constipation, chronic or acute diarrhoea; (13)Have a history of bowel resection surgeries, had gastroenterological or other abdominal surgeries such as cholecystectomy within one year, or had other non-digestive tract surgery within six months; (14)Any situation that affects enrollment as judged by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c; | — |
Secondary
| Measure | Time frame |
|---|---|
| alterations of gut microbiome;Bile acid pool composition;BMI;Lipid profile;Uremic acid;HomaIR;Homabeta; | — |
Countries
China Mainland
Contacts
Public ContactWeiqing Wang
Ruijin hospital affiliated to Jiaotong University Medical School
Outcome results
None listed