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

Tongji University

Status: Unknown

Conditions: Diabetes Mellitus, Type 2

Treatments: Dietary Supplement: probiotics; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02728414

PTD01

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

probiotics

Experimental group

Description:

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

Treatment:

Dietary Supplement: probiotics

placebo

Other group

Description:

the patients in this arm will receive placebo with similar appearance of probiotics.

Treatment:

Dietary Supplement: placebo