This study is aimed at verifying the effects of probiotics (KAWAI:dead S.thermophilus) on glucos management among T2DM and pre-diabetes Chinese adult. Additionally, the investigators intend to verify the effects of probiotics on modifying the structure and function of gut microbiome.
Methods: double-blind, randomized controlled trial. Number of participants: 160 patients with pre-diabetes and 60 diabetes. Intervention time: 3months. Data and Specimen collection time: at baseline and after the intervention. Observation index 1. Physical measurement: gender, age, weight, BMI, waist circumference, hip circumference, waist-to-hip ratio, systolic pressure, diastolic blood pressure. 2. Lifestyle questionnaire: diet, drinking, exercise, sleep and other habits. 3. Blood test: blood glucose, OGTT, blood lipid, TNF-a, il-6, il-10, LPS, glp-1, gut microbiome metabolism products, T2DM related methylation. 4\. Gut microbiome detection: gut microbiome 16Sr DNA sequencing, gut microbiome bioinformatics analysis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
220
the probiotics group was taking probiotics 4 packets a day
the placebo group was taking placebo 4 packets a day
health management center,Southwest hospital
Chongqing, Chongqing Municipality, China
RECRUITINGChanges of blood glucose and insulin sensitivity
blood glucose of fasting and 2 hours after OGTT,fasting insulin
Time frame: 3~5 years
Changes of gut microbiota composition
Feces gut microbiome 16Sr DNA sequencing, gut microbiome bioinformatics analysis
Time frame: 3~5 years
Changes of blood inflammatory markers
blood TNF-a, Il-6, Il-10, LPS
Time frame: 3~5 years
Composite changes in diabetes risk factors
blood pressure, triglyceride,Cholesterol,LDL,HDL, weight
Time frame: 3~5 years
Composite changes of weight, waist circumference and BMI
weight, waist circumference,BMI,body fat
Time frame: 3~5 years
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