This study is a randomized, open labelled, placebo-controlled clinical trial. The main purpose is to verify the superior effect of gut microbiota directed diet intervention over standard diet intervention by evaluating the changes of HbA1c relative to baseline at 16 weeks and 28 weeks of follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
200
Food
Qilu Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGchanges of HbA1c compared with baseline
changes of HbA1c compared with baseline
Time frame: 28 weeks
remission rate
remission rate of T2D by ADA guideline;ratio of subjects whose blood glucose can reach completely normal without drug intervention
Time frame: 28 weeks
control rate
Proportion of subjects with HbA1c \< 7.0%
Time frame: at 16 weeks of treatment and 28 weeks of follow-up
blood lipid profile
Changes of blood lipids (total cholesterol, triglyceride, high density lipoprotein cholesterol, low density lipoprotein cholesterol) relative to baseline
Time frame: at 16 weeks of treatment and 28 weeks of follow-up
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