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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health | No Intervention | ||
| Disease | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food | Dietary Supplement | Food |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes of HbA1c compared with baseline | changes of HbA1c compared with baseline | 28 weeks |
| remission rate | remission rate of T2D by ADA guidelineï¼›ratio of subjects whose blood glucose can reach completely normal without drug intervention | 28 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| control rate | Proportion of subjects with HbA1c < 7.0% | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruxing Zhao, doctor | Contact | 865318219322 | rusingstar@163.com | |
| Jianjun Sun, BS | Contact | 8618916149662 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005502 | Food |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| at 16 weeks of treatment and 28 weeks of follow-up |
| D004700 | Endocrine System Diseases |