Probiotics Effect on Glucose and Lipid Metabolism and Gut Microbiota in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the probiotics is effective in the treatment of type 2 diabetes.

Detailed Description
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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.

Official Title
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Probiotics Effect on Glucose and Lipid Metabolism and Gut Microbiota in Patients With Type 2 Diabetes: a Randomized, Double-blind Controlled Trial

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Dietary Supplement: probiotics
* Dietary Supplement: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20-80 years Confirmed type 2 diabetes patients with Oral antidiabetic agents Agree to cooperate in the trial Provision of written informed consent Exclusion Criteria: With chronic gastrointestinal diseases, severe immune deficiency, lactose intolerance Type 1 diabetes Treated with insulin or an insulin analogue in the last 6 months Use antibiotics, bacteriostatic agents (eg berberine), lipid-lowering drugs, antacids, H2 Blockers, proton pump inhibitors, corticosteroids or sex hormones Use any probiotics in the last 3 months Participating in any other clinical trials Was not able to insist until the end Pregnant and lactating women

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: probiotics<br>the patients in this arm will receive probiotics with a dose for 2g/d for 3 months. | Dietary Supplement: probiotics<br>* the patients in this arm will receive probiotics with a dose for 2g/d for 3 months.<br>|
| Other: placebo<br>the patients in this arm will receive placebo with similar appearance of probiotics. | Dietary Supplement: placebo<br>* the patients in this arm will receive placebo intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2, Probiotics, Treatment