Hyperglycemia Hyperlipidemia
Conditions
Interventions
Experimental group:probiotics+ atorvastatin + metformin
Placebo group:Placebo+ atorvastatin + metformin
Sponsors
The First People's Hospital of Kunshan
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 65 years ; 2.Total cholesterol ( TC ) > 5.17 mmol / L ( 200 mg / dL ), or total triglyceride ( TG ) > 2.3 mmol / L ( 200 mg / dL ) or low density lipoprotein ( LDL-C > 3.64 mmol / L ), or high density lipoprotein ( HDL-C < 1.0 mmol / L ), clinical judgment requires oral atorvastatin as a drug to control hyperlipidemia ; 3. Clinical judgment requires oral metformin as hypoglycemic drugs ; 4.Living in the local for at least half a year, with a fixed residence ; 5. Have not participated in clinical trials of other drugs within 3 months before the trial ; 6.Good compliance, have an urgent desire to change their physical condition ; 7.Subjects or guardians have signed the informed consent form, the basic situation questionnaire, and promised to cooperate with the study throughout the trial
Exclusion criteria
Exclusion criteria: 1.Chronic diseases ( coronary heart disease, immunodeficiency, mental disorders, cancer, liver and kidney dysfunction, etc. ) and complications ; 2. irritable bowel syndrome, ulcerative colitis, Crohn 's disease ; 3.Patients who had taken various lipid-lowering drugs or health care products ( including appetite inhibitors such as fluorophenylalanine and thyroid hormones, progesterone, laxatives, and various traditional Chinese medicine ingredients ) or surgical methods to lose weight in the past month ; 4.take weight control measures ( diet, exercise, etc. ) in the past month ; 5.Antibiotics were used in the past month ; 6.Continuous use of probiotics, prebiotics or synbiotics in the past 14 days ; 7. Obvious movement disorder ; 8.Drinking ( drinking more than 5 times a week, an average of 2 liang of liquor or half a pound of yellow wine or more than 5 bottles of beer ) ; 9.Patients with chronic kidney disease or blood urea nitrogen and creatinine were higher than the upper limit of normal 1.2 times ; patients with chronic liver disease ( ALT, AST higher than 2.0 times the upper limit of normal ) ; acute or chronic pancreatitis ; 10. Pregnant or lactating women ; 11, doctors judge compliance is poor, after evaluation that is not suitable for this clinical researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lipid profiles (total cholesterol, triglycerides, low-density cholesterol, high-density cholesterol);Blood glucose indicators (fasting blood glucose, glycated hemoglobin);Microbiota analysis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight management indicators;GSRS;Liver function indicators(Liver function measures (AST, ALT, and ?-glutamyltransferase)); | — |
Countries
China
Contacts
Public Contactchen xiao hua
The First People's Hospital of Kunshan
Outcome results
None listed