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Effect of Probiotics on Pre-diabetes and Diabetes in China

Primary Purpose

Type 2 Diabetes Mellitus

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

probiotics

placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring pre-diabetes,diabetes,probiotics

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

health management center,Southwest hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

probiotics on type 2 diabetes

probiotics on pre-diabetes

placebo on type 2 diabetes

placebo on pre-diabetes

Arm Description

take probiotics

take placebo

Outcomes

Primary Outcome Measures

Changes of blood glucose and insulin sensitivity

blood glucose of fasting and 2 hours after OGTT，fasting insulin

Changes of gut microbiota composition

Feces gut microbiome 16Sr DNA sequencing, gut microbiome bioinformatics analysis

Secondary Outcome Measures

Changes of blood inflammatory markers

blood TNF-a, Il-6, Il-10, LPS

Composite changes in diabetes risk factors

blood pressure, triglyceride,Cholesterol,LDL,HDL, weight

Composite changes of weight, waist circumference and BMI

weight, waist circumference,BMI,body fat

Full Information

NCT ID

NCT03377946

First Posted

December 10, 2017

Last Updated

December 16, 2017

Sponsor

Chinese PLA General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03377946

Brief Title

Effect of Probiotics on Pre-diabetes and Diabetes in China

Official Title

Effect of Probiotics on Pre-diabetes and Diabetes in China-the Role of Gut Microbiota Composition

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 21, 2017 (Anticipated)

Primary Completion Date

December 31, 2018 (Anticipated)

Study Completion Date

August 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese PLA General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 Physical measurement: gender, age, weight, BMI, waist circumference, hip circumference, waist-to-hip ratio, systolic pressure, diastolic blood pressure. Lifestyle questionnaire: diet, drinking, exercise, sleep and other habits. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

pre-diabetes,diabetes,probiotics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

probiotics on type 2 diabetes

Arm Type

Experimental

Arm Description

take probiotics

Arm Title

probiotics on pre-diabetes

Arm Type

Experimental

Arm Description

take probiotics

Arm Title

placebo on type 2 diabetes

Arm Type

Placebo Comparator

Arm Description

take placebo

Arm Title

placebo on pre-diabetes

Arm Type

Placebo Comparator

Arm Description

take placebo

Intervention Type

Biological

Intervention Name(s)

probiotics

Intervention Description

the probiotics group was taking probiotics 4 packets a day

Intervention Type

Biological

Intervention Name(s)

placebo

Intervention Description

the placebo group was taking placebo 4 packets a day

Primary Outcome Measure Information:

Title

Changes of blood glucose and insulin sensitivity

Description

blood glucose of fasting and 2 hours after OGTT，fasting insulin

Time Frame

3~5 years

Title

Changes of gut microbiota composition

Description

Feces gut microbiome 16Sr DNA sequencing, gut microbiome bioinformatics analysis

Time Frame

3~5 years

Secondary Outcome Measure Information:

Title

Changes of blood inflammatory markers

Description

blood TNF-a, Il-6, Il-10, LPS

Time Frame

3~5 years

Title

Composite changes in diabetes risk factors

Description

blood pressure, triglyceride,Cholesterol,LDL,HDL, weight

Time Frame

3~5 years

Title

Composite changes of weight, waist circumference and BMI

Description

weight, waist circumference,BMI,body fat

Time Frame

3~5 years

Other Pre-specified Outcome Measures:

Title

Changes of Intestinal endocrine function

Description

Blood GLP-1

Time Frame

3~5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Meet Diabetes/pre-diabetes diagnostic criteria BMI 18-35kg/m2 Exclusion Criteria: Patients with diabetes or hyperlipidemia, and need regular use of drugs. Secondary obesity or diabetes Digestive, tumor, heart, lung, kidney, rheumatic immunity and other systemic serious diseases Pregnant women, women ready for pregnancy, and nursing mothers Take antibiotics or bacterial agents within 1 month Diarrhea or abscess in 1 month or blood or other abnormal feces Diabetics have a history of more than 2 years The OGTT experiment of diabetic patients FG≥9mmol/L or 2h≥14mmol/L

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fei Wang, MD

Phone

+86-10-68295950

wangfei301hmi@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qiang Zeng, MD

Organizational Affiliation

Chinese PLA General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

health management center,Southwest hospital

City

Chongqing

State/Province

Chongqing

ZIP/Postal Code

400030

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ya lan zhang, MD

Phone

13594348611

281072454@qq.com

First Name & Middle Initial & Last Name & Degree

xiao lan zhao, MD

Phone

13608303976

zhaoxiaolan65@126.com

12. IPD Sharing Statement

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Effect of Probiotics on Pre-diabetes and Diabetes in China

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