Probiotics Effect on Glucose and Lipid Metabolism and Gut Microbiota in Patients With Type 2 Diabetes
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether the probiotics is effective in the treatment of type 2 diabetes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: probiotics the patients in this arm will receive probiotics with a dose for 2g/d for 3 months. |
Dietary Supplement: probiotics
the patients in this arm will receive probiotics with a dose for 2g/d for 3 months.
|
| Other: placebo the patients in this arm will receive placebo with similar appearance of probiotics. |
Dietary Supplement: placebo
the patients in this arm will receive placebo intervention
|
Outcome Measures
Primary Outcome Measures
- change from baseline in fasting blood-glucose at 1 month [1 month]
change of the fasting blood-glucose will be calculated at 1 month in comparison with the baseline
- change from baseline in fasting blood-glucose at 3 months [3 months]
change of the fasting blood-glucose will be calculated at 3 months in comparison with the baseline
- change from baseline in glycosylated hemoglobin change at 1 month [1 month]
change of the glycosylated hemoglobin will be calculated at 1 month in comparison with the baseline
- change from baseline in glycosylated hemoglobin change at 3 months [3 months]
change of the glycosylated hemoglobin will be calculated at 3 months in comparison with the baseline
Secondary Outcome Measures
- change from baseline in gut microbiota at 1 month [1 month]
study the microbiota change of stool samples at 1 month in comparison with the baseline
- change from baseline in gut microbiota at 3 months [3 months]
study the microbiota change of stool samples at 3 months in comparison with the baseline
- 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]
Eligibility Criteria
Criteria
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
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Treated with insulin or an insulin analogue in the last 6 months
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Use antibiotics, bacteriostatic agents (eg berberine), lipid-lowering drugs, antacids, H2 Blockers, proton pump inhibitors, corticosteroids or sex hormones
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Use any probiotics in the last 3 months
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Participating in any other clinical trials
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Was not able to insist until the end
-
Pregnant and lactating women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai 10th People's Hospital | Shanghai | Shanghai | China | 200072 |
Sponsors and Collaborators
- Shanghai 10th People's Hospital
Investigators
- Principal Investigator: Huanlong Qin, PhD, Shanghai 10th People's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PTD01