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The purpose of this study is to determine whether the probiotics is effective in the treatment of type 2 diabetes.
This study aims to evaluate the effect of probiotics on the improvement of glucose and lipid metabolism, as well as the gut microbiota.Baseline, 1 month and 3 month data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical practice for type 2 diabetes patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| probiotics | Experimental | the patients in this arm will receive probiotics with a dose for 2g/d for 3 months. |
|
| placebo | Other | the patients in this arm will receive placebo with similar appearance of probiotics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| probiotics | Dietary Supplement | the patients in this arm will receive probiotics with a dose for 2g/d for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in fasting blood-glucose at 1 month | change of the fasting blood-glucose will be calculated at 1 month in comparison with the baseline | 1 month |
| change from baseline in fasting blood-glucose at 3 months | change of the fasting blood-glucose will be calculated at 3 months in comparison with the baseline | 3 months |
| change from baseline in glycosylated hemoglobin change at 1 month | change of the glycosylated hemoglobin will be calculated at 1 month in comparison with the baseline | 1 month |
| change from baseline in glycosylated hemoglobin change at 3 months | change of the glycosylated hemoglobin will be calculated at 3 months in comparison with the baseline | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in gut microbiota at 1 month | study the microbiota change of stool samples at 1 month in comparison with the baseline | 1 month |
| change from baseline in gut microbiota at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cuiling Zhu, MD | Contact | 18817951953l | 1263856671@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Huanlong Qin, PhD | Shanghai 10th People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai 10th People's Hospital | Recruiting | Shanghai | Shanghai Municipality | 200072 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| placebo | Dietary Supplement | the patients in this arm will receive placebo intervention |
|
study the microbiota change of stool samples at 3 months in comparison with the baseline
| 3 months |
| change from baseline in triglyceride at 1 month | 1 month |
| change from baseline in triglyceride at 3 months | 3 months |
| change from baseline in cholesterol at 1 month | 1 month |
| change from baseline in cholesterol at 3 months | 3 months |
| change from baseline in high-density lipoprotein at 1 month | 1 month |
| change from baseline in high-density lipoprotein at 3 months | 3 months |
| change from baseline in low-density lipoprotein at 1 month | 1 month |
| change from baseline in low-density lipoprotein at 3 months | 3 months |
| change from baseline in glutamic oxalacetic transaminase at 1 month | 1 month |
| change from baseline in glutamic oxalacetic transaminase at 3 months | 3 months |
| change from baseline in alkaline transaminase at 1 month | 1 month |
| change from baseline in alkaline transaminase at 3 months | 3 months |
| change from baseline in alkaline phosphatase at 1 month | 1 month |
| change from baseline in alkaline phosphatase at 3 months | 3 months |
| change from baseline in superoxide dismutase at 1 month | 1 month |
| change from baseline in superoxide dismutase at 3 months | 3 months |
| change from baseline in C-reactive protein at 1 month | 1 month |
| change from baseline in C-reactive protein at 3 months | 3 months |
| change from baseline in uric acid at 1 month | 1 month |
| change from baseline in uric acid at 3 months | 3 months |
| change from baseline in tumor necrosis factor-a at 1 month | 1 month |
| change from baseline in tumor necrosis factor-a at 3 months | 3 months |
| change from baseline in interleukin-6 at 1 month | 1 month |
| change from baseline in interleukin-6 at 3 months | 3 months |
| change from baseline in interleukin-8 at 1 month | 1 month |
| change from baseline in interleukin-8 at 3 months | 3 months |
| change from baseline in fasting insulin at 1 month | 1 month |
| change from baseline in fasting insulin at 3 months | 3 months |
| change from baseline in c peptide at 1 month | 1 month |
| change from baseline in c peptide at 3 months | 3 months |
| D019602 |
| Food and Beverages |