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

Shanghai 10th People's Hospital100 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Diabetes Mellitus, Type 2

Interventions

probioticsDIETARY_SUPPLEMENT

the patients in this arm will receive probiotics with a dose for 2g/d for 3 months.

placeboDIETARY_SUPPLEMENT

the patients in this arm will receive placebo intervention

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 3 months

Secondary Outcomes

change from baseline in gut microbiota at 1 month

study the microbiota change of stool samples at 1 month in comparison with the baseline

Time frame: 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

Time frame: 3 months

change from baseline in triglyceride at 1 month

Time frame: 1 month

change from baseline in triglyceride at 3 months

Time frame: 3 months

Central Contacts

Cuiling Zhu, MD

CONTACT

18817951953l 1263856671@qq.com

Data from ClinicalTrials.gov

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