The aim of this study is to assess the beneficial effects of Bifidobacterium and Berberine Hydrochloride on lowering glucose and delaying progress to diabetes in patients with prediabetes and to detect the potential mechanism.
Gut microbiota may play an important role in patients with prediabetes. Berberine, which is usually used as an antibiotic drug, has been reported a potential glucose-lowering effect in vitro and in vivo studies. Bifidobacterium, as a familiar probiotics, can modulate gut microbiota and improve glucose and lipid metabolism in animal experiments. Therefore, the aim of this study is to assess the beneficial effects of Bifidobacterium and Berberine Hydrochloride on lowering glucose and delaying progress to diabetes in patients with prediabetes and to detect the potential mechanism.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
Change of absolute value of fasting plasma glucose (mmol/L)
Fasting plasma glucose will be measured during oral glucose tolerance test (OGTT) by glucose oxidase method at baseline and week 16.
Time frame: baseline and week 16
Change of absolute value of 2-hour postprandial plasma glucose (mmol/L)
2-hour postprandial plasma glucose will be measured during OGTT by glucose oxidase method at baseline and week 16.
Time frame: baseline and week 16
Change of level of HbA1c (%)
HbA1c will be tested in plasma by high-performance liquid chromatography at baseline and week 16.
Time frame: baseline and week 16
Change of level of systolic pressure (mmHg)
Systolic pressure will be measured by mercurial sphygmomanometer using the standard methods at baseline and week 16.
Time frame: baseline and week 16
Change of level of diastolic pressure (mmHg)
Diastolic pressure will be measured by mercurial sphygmomanometer using the standard methods at baseline and week 16.
Time frame: baseline and week 16
Change of level of serum total cholesterol (mmol/L)
Serum total cholesterol will be measured by fully automatic biochemical analyser at baseline and week 16.
Time frame: baseline and week 16
Change of level of low-density lipoprotein cholesterol (mmol/L)
Serum low-density lipoprotein cholesterol will be measured by fully automatic biochemical analyser at baseline and week 16.
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Time frame: baseline and week 16
Change of level of high-density lipoprotein cholesterol (mmol/L)
Serum high-density lipoprotein cholesterol will be measured by fully automatic biochemical analyser at baseline and week 16.
Time frame: baseline and week 16
Change of level of triglycerides (mmol/L)
Serum triglycerides will be measured by fully automatic biochemical analyser at baseline and week 16.
Time frame: baseline and week 16
Change of absolute value of body weight (kg)
Body weight will be measured by weighing scale using the standard methods at baseline and week 16.
Time frame: baseline and week 16
Change of absolute value of body mass index (BMI) (kg/m^2)
Weight and height will be combined to report BMI in kg/m\^2 at baseline and week 16.
Time frame: baseline and week 16
Change of level of homeostasis model assessment (HOMA) index
Fasting serum insulin and fasting plasma glucose will be calculated for HOMA index at baseline and week 16.
Time frame: baseline and week 16
Change of level of insulin early-phase secretion index
Fasting serum insulin and 30 min post serum insulin during OGTT will be calculated for early-phase secretion index at baseline and week 16 .
Time frame: baseline and week 16
Change of level of insulin late-phase secretion index
Fasting serum insulin and 2-hour post serum insulin during OGTT will be calculated for late-phase secretion index at baseline and week 16 .
Time frame: baseline and week 16
Change of level of GLP-1(pmol/L)
GLP-1 will be measured in serum by ELISA KIT at baseline and week 16.
Time frame: baseline and week 16
Change of abundances of gut microbiota (%)
Fecal samples will be measured by metagenomic sequencing to obtain abundances of gut microbiota at baseline and week 16.
Time frame: baseline and week 16