Effect of Probiotics on Pre-diabetes and Diabetes in China

Chinese PLA General Hospital (301 Hospital)

Status: Unknown

Conditions: Type 2 Diabetes Mellitus

Treatments: Biological: probiotics; Biological: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03377946

CHPF2017019

Details and patient eligibility

About

This study is aimed at verifying the effects of probiotics (KAWAI:dead S.thermophilus) on glucos management among T2DM and pre-diabetes Chinese adult. Additionally, the investigators intend to verify the effects of probiotics on modifying the structure and function of gut microbiome.

Full description

Methods: double-blind, randomized controlled trial. Number of participants: 160 patients with pre-diabetes and 60 diabetes. Intervention time: 3months. Data and Specimen collection time: at baseline and after the intervention.

Observation index

1. Physical measurement: gender, age, weight, BMI, waist circumference, hip circumference, waist-to-hip ratio, systolic pressure, diastolic blood pressure.

2. Lifestyle questionnaire: diet, drinking, exercise, sleep and other habits.

3. Blood test: blood glucose, OGTT, blood lipid, TNF-a, il-6, il-10, LPS, glp-1, gut microbiome metabolism products, T2DM related methylation.

4. Gut microbiome detection: gut microbiome 16Sr DNA sequencing, gut microbiome bioinformatics analysis

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Meet Diabetes/pre-diabetes diagnostic criteria
2. BMI 18-35kg/m2

Exclusion criteria

1. Patients with diabetes or hyperlipidemia, and need regular use of drugs.
2. Secondary obesity or diabetes
3. Digestive, tumor, heart, lung, kidney, rheumatic immunity and other systemic serious diseases
4. Pregnant women, women ready for pregnancy, and nursing mothers
5. Take antibiotics or bacterial agents within 1 month
6. Diarrhea or abscess in 1 month or blood or other abnormal feces
7. Diabetics have a history of more than 2 years
8. The OGTT experiment of diabetic patients FG≥9mmol/L or 2h≥14mmol/L

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 4 patient groups, including a placebo group

probiotics on type 2 diabetes

Experimental group

Description:

take probiotics

Treatment:

Biological: probiotics

probiotics on pre-diabetes

Experimental group

Description:

take probiotics

Treatment:

Biological: probiotics

placebo on type 2 diabetes

Placebo Comparator group

Description:

take placebo

Treatment:

Biological: placebo

placebo on pre-diabetes

Placebo Comparator group

Description:

take placebo

Treatment:

Biological: placebo