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This study is aimed at verifying the effects of probiotics (KAWAI:dead S.thermophilus) on glucos management among T2DM and pre-diabetes Chinese adult. Additionally, the investigators intend to verify the effects of probiotics on modifying the structure and function of gut microbiome.
Methods: double-blind, randomized controlled trial. Number of participants: 160 patients with pre-diabetes and 60 diabetes. Intervention time: 3months. Data and Specimen collection time: at baseline and after the intervention.
Observation index
4. Gut microbiome detection: gut microbiome 16Sr DNA sequencing, gut microbiome bioinformatics analysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| probiotics on type 2 diabetes | Experimental | take probiotics |
|
| probiotics on pre-diabetes | Experimental | take probiotics |
|
| placebo on type 2 diabetes | Placebo Comparator | take placebo |
|
| placebo on pre-diabetes | Placebo Comparator | take placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| probiotics | Biological | the probiotics group was taking probiotics 4 packets a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of blood glucose and insulin sensitivity | blood glucose of fasting and 2 hours after OGTT，fasting insulin | 3~5 years |
| Changes of gut microbiota composition | Feces gut microbiome 16Sr DNA sequencing, gut microbiome bioinformatics analysis | 3~5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of blood inflammatory markers | blood TNF-a, Il-6, Il-10, LPS | 3~5 years |
| Composite changes in diabetes risk factors | blood pressure, triglyceride,Cholesterol,LDL,HDL, weight |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Intestinal endocrine function | Blood GLP-1 | 3~5 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fei Wang, MD | Contact | +86-10-68295950 | wangfei301hmi@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Qiang Zeng, MD | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| health management center,Southwest hospital | Recruiting | Chongqing | Chongqing Municipality | 400030 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 10, 2017 | Dec 10, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 10, 2017 | Dec 10, 2017 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic 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 | Biological | the placebo group was taking placebo 4 packets a day |
|
| 3~5 years |
| Composite changes of weight, waist circumference and BMI | weight, waist circumference,BMI,body fat | 3~5 years |
| D004700 | Endocrine System Diseases |
| D006943 | Hyperglycemia |
| D019602 |
| Food and Beverages |