Effect of Probiotics on Pre-diabetes and Diabetes in China

Not Applicable

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Biological: placebo; Biological: probiotics

• Registration Number: NCT03377946
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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.

Detailed 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

Study Timeline

• Status Verified: 2017-12
• Study First Submitted: 2017-12-10
• Study First Submitted QC: 2017-12-16
• Last Update Submitted: 2017-12-16
• Study First Posted: 2017-12-19
• Last Update Posted: 2017-12-19
• Study Start: 2017-12-21
• Primary Completion: 2018-12-31
• Study Completion: 2019-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo on type 2 diabetes	placebo	take placebo
probiotics on type 2 diabetes	probiotics	take probiotics
probiotics on pre-diabetes	probiotics	take probiotics
placebo on pre-diabetes	placebo	take placebo

Primary Outcome Measures

Name	Time	Method
Changes of blood glucose and insulin sensitivity	3~5 years	blood glucose of fasting and 2 hours after OGTT，fasting insulin
Changes of gut microbiota composition	3~5 years	Feces gut microbiome 16Sr DNA sequencing, gut microbiome bioinformatics analysis

Secondary Outcome Measures

Name	Time	Method
Changes of blood inflammatory markers	3~5 years	blood TNF-a, Il-6, Il-10, LPS
Composite changes in diabetes risk factors	3~5 years	blood pressure, triglyceride,Cholesterol,LDL,HDL, weight
Composite changes of weight, waist circumference and BMI	3~5 years	weight, waist circumference,BMI,body fat

Trial Locations

Locations (1)

health management center,Southwest hospital; 🇨🇳 Chongqing, Chongqing, China