Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus, Type 2, Probiotics, Treatment
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.
Interventions
DIETARY_SUPPLEMENTplacebo
the patients in this arm will receive placebo intervention
DIETARY_SUPPLEMENTprobiotics
the patients in this arm will receive probiotics with a dose for 2g/d for 3 months.
Sponsors
Shanghai 10th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 20-80 years 2. Confirmed type 2 diabetes patients with Oral antidiabetic agents 3. Agree to cooperate in the trial 4. Provision of written informed consent
Exclusion criteria
1. With chronic gastrointestinal diseases, severe immune deficiency, lactose intolerance 2. Type 1 diabetes 3. Treated with insulin or an insulin analogue in the last 6 months 4. Use antibiotics, bacteriostatic agents (eg berberine), lipid-lowering drugs, antacids, H2 Blockers, proton pump inhibitors, corticosteroids or sex hormones 5. Use any probiotics in the last 3 months 6. Participating in any other clinical trials 7. Was not able to insist until the end 8. Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 cholesterol at 1 month | 1 month | — |
| change from baseline in triglyceride at 1 month | 1 month | — |
| 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 cholesterol at 3 months | 3 months | — |
| change from baseline in triglyceride 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 | — |
Countries
China
Contacts
Primary ContactCuiling Zhu, MD
Outcome results
None listed