Type 2 Diabetes Mellitus Clinical Trial
Official title:
Effect of Probiotics on Pre-diabetes and Diabetes in China-the Role of Gut Microbiota Composition
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
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