Probiotics Effect on Glucose and Lipid Metabolism and Gut Microbiota in Patients With Type 2 Diabetes
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Dietary Supplement: probioticsDietary Supplement: placebo
- Registration Number
- NCT02728414
- Lead Sponsor
- Shanghai 10th People's Hospital
- Brief Summary
The purpose of this study is to determine whether the probiotics is effective in the treatment of type 2 diabetes.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Age 20-80 years
- Confirmed type 2 diabetes patients with Oral antidiabetic agents
- Agree to cooperate in the trial
- Provision of written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description probiotics probiotics the patients in this arm will receive probiotics with a dose for 2g/d for 3 months. placebo placebo the patients in this arm will receive placebo with similar appearance of probiotics.
- Primary Outcome Measures
Name Time Method 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
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 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 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
- Secondary Outcome Measures
Name Time Method change from baseline in low-density lipoprotein at 1 month 1 month 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 triglyceride at 1 month 1 month change from baseline in glutamic oxalacetic transaminase at 3 months 3 months change from baseline in C-reactive protein 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 triglyceride at 3 months 3 months change from baseline in cholesterol at 1 month 1 month change from baseline in high-density lipoprotein at 1 month 1 month change from baseline in glutamic oxalacetic transaminase at 1 month 1 month 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 cholesterol at 3 months 3 months change from baseline in high-density lipoprotein at 3 months 3 months change from baseline in low-density lipoprotein 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 interleukin-6 at 1 month 1 month 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 uric acid at 1 month 1 month change from baseline in uric acid 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 c peptide at 1 month 1 month change from baseline in c peptide at 3 months 3 months change from baseline in tumor necrosis factor-a at 3 months 3 months change from baseline in tumor necrosis factor-a at 1 month 1 month change from baseline in interleukin-6 at 3 months 3 months
Trial Locations
- Locations (1)
Shanghai 10th People's Hospital
🇨🇳Shanghai, Shanghai, China