T2DM
Conditions
Interventions
intervention group:Powder (10^10 CFU/sachet in formulations containing Enterobacteriaceae), one sachet to be taken orally twice daily (morning and evening after meals).
control group:placebo-controlled study
Sponsors
The First Affiliated Hospital of University of Science and Technology of China, Anhui Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: In this study, we will recruit patients who (1) voluntarily participate in this clinical trial; (2) age: 18-75 years old; (3) women with a BMI =24 kg/m2 or waist circumference =80 cm or men with a waist circumference =90 cm; (4) meet the diagnosis of type 2 diabetes mellitus (typical symptoms of diabetes mellitus plus random blood glucose =11.1 mmol/L or plus fasting blood glucose =7.0 mmol /L or plus OGTT 2 h blood glucose =11.1mmol/L or plus HbA1c =48mmol/mol i.e. 6.5%, for those without typical symptoms of diabetes mellitus, need to be rechecked on another day to confirm), do not use any hypoglycemic drugs in the last 3 months, only diet and exercise to control blood glucose, and HbA1c <58mmol/mol i.e. 7.5%.
Exclusion criteria
Exclusion criteria: Patients will not be included if they (1) have taken oral antibiotics, probiotics, prebiotics in the last 1 month, or corticosteroids (glucocorticoids) or immunosuppressants in the last 3 months; (2) have taken fermented products such as yoghurt, pickles, sauerkraut, etc. in the last 2 weeks, or are allergic to intervening agents; (3) have had a self-reported change in body weight in the 90 days prior to screening of more than 5 kg; (4) a disease or lifestyle habit that may affect weight regulation such as thyroid disease, eating disorders, etc.; (5) a disease of the digestive tract (e.g., chronic diarrhoea or severe constipation) or a history of intestinal resection or other gastrointestinal tract surgery (e.g., cholecystectomy) within the past 1 year or other non-gastrointestinal tract surgery in the past 6 months; and (6) severe hepatic insufficiency, defined as serum alanine aminotransferase concentration exceeding more than 2.5 times the upper limit of the normal range. or impaired renal function (defined as serum creatinine > 132 umol/L or estimated glomerular filtration rate (eGFR) < 60 mmol/L, or psychiatric or neurological disorders, severe infections, severe anaemia or neutropenia; (7) severe organic heart disease, including but not limited to congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy or New York Heart Association (NYHA) class cardiac function = class III; (8) history of malignancy (other than localised basal cell carcinoma of the skin) within the past 5 years, with or without evidence of recurrence or metastasis; (9) pregnant or breastfeeding women, or planning a pregnancy in the next 6 months; (10) history of abuse of alcohol, drugs, or other substances predisposing to dependence; (11) participation in other clinical trial; (12) any condition that, in the opinion of the investigator, may interfere with the results of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c levels; | — |
Secondary
| Measure | Time frame |
|---|---|
| obesity improvement;pancreatic function;Changes in selected human biochemical parameters;safety; | — |
Countries
china
Contacts
Public ContactWeng Jianping
The First Affiliated Hospital of University of Science and Technology of China, Anhui Provincial Hospital
Outcome results
None listed