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| Name | Class |
|---|---|
| Second Affiliated Hospital of Xi'an Jiaotong University | OTHER |
| Yan'an University Affiliated Hospital | OTHER |
| Shaanxi Aerospace Hospital | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Berberine Hydrochloride group | Experimental | 2/day, 16 weeks |
|
| Bifidobacterium group | Experimental | 2/day, 16 weeks |
|
| Berberine Hydrochloride and Bifidobacterium group | Experimental | 2/day, 16 weeks |
|
| placebo | Placebo Comparator | bifidobacterium mimetic capsules berberine mimetic tablets,2/day, 16 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berberine Hydrochloride group | Drug |
| ||
| Bifidobacterium group |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and week 16 |
| Change of level of HbA1c (%) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qiuhe Ph.D. Ji, M.D. | Department of Endocrinology,Xi jing Hospital,Fourth Military Medical University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34365978 | Derived | Ming J, Yu X, Xu X, Wang L, Ding C, Wang Z, Xie X, Li S, Yang W, Luo S, He Q, Du Y, Tian Z, Gao X, Ma K, Fang Y, Li C, Zhao J, Wang X, Ji Q. Effectiveness and safety of Bifidobacterium and berberine in human hyperglycemia and their regulatory effect on the gut microbiota: a multi-center, double-blind, randomized, parallel-controlled study. Genome Med. 2021 Aug 9;13(1):125. doi: 10.1186/s13073-021-00942-7. | |
| 29373989 |
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| Genertec Universal Xi'an Aero-Engine hospital (Xi' an) Co., Ltd |
| UNKNOWN |
| Xi'an Gaoxin Hospital | OTHER |
| Chang'An Hospital | OTHER |
| Xi'an Central Hospital | OTHER |
| Yan'an People's Hospital | OTHER |
| Shangluo Central Hospital | OTHER |
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| Drug |
|
| Berberine Hydrochloride and Bifidobacterium group | Drug |
|
| placebo | Drug |
|
HbA1c will be tested in plasma by high-performance liquid chromatography at baseline and week 16.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 . | 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 . | 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. | 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. | baseline and week 16 |
| Derived |
| Ming J, Xu S, Liu C, Liu X, Jia A, Ji Q. Effectiveness and safety of bifidobacteria and berberine in people with hyperglycemia: study protocol for a randomized controlled trial. Trials. 2018 Jan 26;19(1):72. doi: 10.1186/s13063-018-2438-5. |