Berberine Hydrochloride
Conditions
Keywords
Bifidobacterium, People With Abnormal Glucose Level
Brief summary
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.
Detailed description
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.
Interventions
DRUGBerberine Hydrochloride and Bifidobacterium group
DRUGplacebo
Sponsors
Second Affiliated Hospital of Xi'an Jiaotong University
Yan'an University Affiliated Hospital
Shaanxi Aerospace Hospital
Genertec Universal Xi'an Aero-Engine hospital (Xi' an) Co., Ltd
Xi'an Gaoxin Hospital
Chang'An Hospital
Xi'an Central Hospital
Yan'an people's Hospital
Shangluo Central Hospital
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any trial-related activities. * Male or female between 18 and 70 years of old. * 19≤Body mass index(BMI)≤30kg/m\^2. * No participate in any clinical trial at least 3 months. * Diagnosed impaired fasting glucose(IFG) and impaired glucose tolerance(IGT) or Diabetes. * In visit 1, 5.60mmol/L≤Fasting plasma glucose(FPG)\<8.0mmol/L; in visit 2, 6.1≤FPG\<8.0mmol/L or 7.8≤2-hour postprandial plasma glucose(2h-PPG) \<17mmol/L. * Females in child-bearing period should be given birth control. * No severe disease about heart, lung and kidney.
Exclusion criteria
* Type 1 diabetes * Diabetes patients with previously treated or untreated FPG ≥ 8 mmol/L or 2-h PPG ≥ 17 mmol/L; * Women of childbearing potential who are pregnant, breastfeeding or intend to become pregnant or are not using adequate contraceptive methods. * Those who are allergic to study drugs * Unable to cooperate * Abnormal liver function, ALT and AST are more than 2 times of the normal upper limit * Renal injury, blood creatinine ≥133 µmol/L * Poor blood pressure control, systolic blood pressure SBP≥160mmHg and/or diastolic blood pressure DBP≥95mmHg * Patients with chronic gastrointestinal diseases (pancreatitis, inflammatory bowel disease) and history of intestinal surgery * Patients with severe heart disease, such as heart failure, unstable angina pectoris, acute myocardial infarction * Chronic hypoxic diseases such as emphysema, pulmonary heart disease * Having obvious diseases of the blood system * Persons with tumor diseases * Endocrine diseases, such as hyperthyroidism and hypercortisolism * Mental illness, abuse of alcohol, drugs or other substances * Persons with long-term oral or intravenous corticosteroid hormones therapy * Having stress conditions such as surgery, severe trauma, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of absolute value of fasting plasma glucose (mmol/L) | baseline and week 16 | Fasting plasma glucose will be measured during oral glucose tolerance test (OGTT) by glucose oxidase method at baseline and week 16. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of absolute value of 2-hour postprandial plasma glucose (mmol/L) | baseline and week 16 | 2-hour postprandial plasma glucose will be measured during OGTT by glucose oxidase method at baseline and week 16. |
| Change of level of HbA1c (%) | baseline and week 16 | HbA1c will be tested in plasma by high-performance liquid chromatography at baseline and week 16. |
| Change of level of systolic pressure (mmHg) | baseline and week 16 | Systolic pressure will be measured by mercurial sphygmomanometer using the standard methods at baseline and week 16. |
| Change of level of serum total cholesterol (mmol/L) | baseline and week 16 | Serum total cholesterol will be measured by fully automatic biochemical analyser at baseline and week 16. |
| Change of level of low-density lipoprotein cholesterol (mmol/L) | baseline and week 16 | Serum low-density lipoprotein cholesterol will be measured by fully automatic biochemical analyser at baseline and week 16. |
| Change of level of high-density lipoprotein cholesterol (mmol/L) | baseline and week 16 | Serum high-density lipoprotein cholesterol will be measured by fully automatic biochemical analyser at baseline and week 16. |
| Change of level of triglycerides (mmol/L) | baseline and week 16 | Serum triglycerides will be measured by fully automatic biochemical analyser at baseline and week 16. |
| Change of level of diastolic pressure (mmHg) | baseline and week 16 | Diastolic pressure will be measured by mercurial sphygmomanometer using the standard methods at baseline and week 16. |
| Change of absolute value of body mass index (BMI) (kg/m^2) | baseline and week 16 | Weight and height will be combined to report BMI in kg/m\^2 at baseline and week 16. |
| Change of level of homeostasis model assessment (HOMA) index | baseline and week 16 | Fasting serum insulin and fasting plasma glucose will be calculated for HOMA index at baseline and week 16. |
| Change of level of insulin early-phase secretion index | baseline and week 16 | Fasting serum insulin and 30 min post serum insulin during OGTT will be calculated for early-phase secretion index at baseline and week 16 . |
| Change of level of insulin late-phase secretion index | baseline and week 16 | Fasting serum insulin and 2-hour post serum insulin during OGTT will be calculated for late-phase secretion index at baseline and week 16 . |
| Change of level of GLP-1(pmol/L) | baseline and week 16 | GLP-1 will be measured in serum by ELISA KIT at baseline and week 16. |
| Change of abundances of gut microbiota (%) | baseline and week 16 | Fecal samples will be measured by metagenomic sequencing to obtain abundances of gut microbiota at baseline and week 16. |
| Change of absolute value of body weight (kg) | baseline and week 16 | Body weight will be measured by weighing scale using the standard methods at baseline and week 16. |
Outcome results
None listed