Obesity
Conditions
Interventions
Control Group:A placebo control was given
a probiotics preparation of Akkermansia muciniphila:a probiotics preparation of Akkermansia muciniphila was given
A new strain of Akkermansia muciniphila muciniphila:A new strain of Akkermansia muciniphila will be administrated
Sponsors
The First Affiliated Hospital of Jinan University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) age =18 years and =60 years, no gender limitation, (2) body mass index (BMI)=28 kg/m2, (3) obesity, type 2 diabetes mellitus, or no type 2 diabetes mellitus according to WHO diagnostic criteria; (4) not taking any medicine for obesity or diabetes for at least 3 months, (5) the hemoglobin a _ 1C (HBA _ 1C) was between 7.0% and 12.0% (including 7.0% and 12.0%) ; (6) those who are willing and able to use the scale and blood glucose meter for self-monitoring according to the requirements of the program; (7) those who are able to comply with the treatment program decided by the researcher; (8) to understand the research, to volunteer and to sign the informed consent before the trial.
Exclusion criteria
Exclusion criteria: (1) those who were known to be allergic to antibiotics and bacterial components (2) those who used antibiotics continuously for 7 days or more within 1 month before screening, those who used weight loss or diabetes treatment, and those who used drugs; (3) the patients who had used drugs within 3 months before screening were judged not suitable for the study group, (4) the patients with liver and renal dysfunction: ALT/AST was higher than the normal value, the upper limit was 2.5 times; Serum creatinine (CR) was 1.2 times higher than the upper limit of normal; (5) uncontrolled hypoglycemia or hyperglycemia was judged by the investigators; (6) patients with severe obesity syndrome, or any other systemic diseases considered to be possible to interfere with the results of this study, including moderate and severe anemia (hemoglobin =90g/L) , mental disorders, etc. (7) those who had heart disease in the 12 months before screening, included: · Decompensated Heart Failure (New York College of Cardiology [ NYHA ] Class III-IV) · Unstable angina · Myocardial infarction (8) in patients with severe hypertension (systolic blood pressure =180 mm Hg and/or diastolic blood pressure =110 mm Hg) ; (9) who had a history of surgery within 6 months before screening and planned treatment during the study period; (10) women with a known pregnancy (determined by a pregnancy test at screening) , who were preparing for pregnancy or who were lactating during the trial period; Or women of childbearing age who do not use adequate contraception (adequate contraception refers to Intrauterine device, oral medication and barriers) ; (11) those who had a history of drug abuse and alcohol dependence within 5 years before screening (12) those who had participated in other interventional clinical trials within 3 months before screening; and (13) those who were not considered suitable by other investigators to participate in this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| bile acids in blood and feces;food intake;excretion of lipids;Short chain fatty acids in blood, urine and feces; | — |
Primary
| Measure | Time frame |
|---|---|
| weight;Blood lipids;Faecal Flora;blood glucose;liver fat content;insulin level and sensitivity; | — |
Countries
China
Contacts
Public ContactJia Shiqi
The First Affiliated Hospital of Jinan University
Outcome results
None listed