Effect of Probiotics on Pre-diabetes and Diabetes in China

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Physical measurement: gender, age, weight, BMI, waist circumference, hip circumference, waist-to-hip ratio, systolic pressure, diastolic blood pressure. Lifestyle questionnaire: diet, drinking, exercise, sleep and other habits. Blood test: blood glucose, OGTT, blood lipid, TNF-a, il-6, il-10, LPS, glp-1, gut microbiome metabolism products, T2DM related methylation. 4. Gut microbiome detection: gut microbiome 16Sr DNA sequencing, gut microbiome bioinformatics analysis

Official Title
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Effect of Probiotics on Pre-diabetes and Diabetes in China-the Role of Gut Microbiota Composition

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Biological: probiotics
* Biological: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet Diabetes/pre-diabetes diagnostic criteria BMI 18-35kg/m2 Exclusion Criteria: Patients with diabetes or hyperlipidemia, and need regular use of drugs. Secondary obesity or diabetes Digestive, tumor, heart, lung, kidney, rheumatic immunity and other systemic serious diseases Pregnant women, women ready for pregnancy, and nursing mothers Take antibiotics or bacterial agents within 1 month Diarrhea or abscess in 1 month or blood or other abnormal feces Diabetics have a history of more than 2 years The OGTT experiment of diabetic patients FG≥9mmol/L or 2h≥14mmol/L

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: probiotics on type 2 diabetes<br>take probiotics | Biological: probiotics<br>* the probiotics group was taking probiotics 4 packets a day<br>|
| Experimental: probiotics on pre-diabetes<br>take probiotics | Biological: probiotics<br>* the probiotics group was taking probiotics 4 packets a day<br>|
| Placebo Comparator: placebo on type 2 diabetes<br>take placebo | Biological: placebo<br>* the placebo group was taking placebo 4 packets a day<br>|
| Placebo Comparator: placebo on pre-diabetes<br>take placebo | Biological: placebo<br>* the placebo group was taking placebo 4 packets a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 3 5 years | 
| Composite changes of weight, waist circumference and BMI | weight, waist circumference,BMI,body fat | 3 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pre-diabetes,diabetes,probiotics