Effect of Probiotics on Pre-diabetes and Diabetes in China

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03377946
• Other study ID #: CHPF2017019
• Status: Recruiting
• Phase: N/A
• First received: December 10, 2017
• Last updated: December 16, 2017
• Start date: December 21, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: December 2017
• Source: Chinese PLA General Hospital
• Contact: Fei Wang, MD
• Phone: +86-10-68295950
• Email: wangfei301hmi[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: August 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Prediabetic State
• Type 2 Diabetes Mellitus

Intervention

Biological:
• probiotics
the probiotics group was taking probiotics 4 packets a day
• placebo
the placebo group was taking placebo 4 packets a day

Locations

Country	Name	City	State
China	health management center,Southwest hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes of Intestinal endocrine function	Blood GLP-1	3~5 years
Primary	Changes of blood glucose and insulin sensitivity	blood glucose of fasting and 2 hours after OGTT,fasting insulin	3~5 years
Primary	Changes of gut microbiota composition	Feces gut microbiome 16Sr DNA sequencing, gut microbiome bioinformatics analysis	3~5 years
Secondary	Changes of blood inflammatory markers	blood TNF-a, Il-6, Il-10, LPS	3~5 years
Secondary	Composite changes in diabetes risk factors	blood pressure, triglyceride,Cholesterol,LDL,HDL, weight	3~5 years
Secondary	Composite changes of weight, waist circumference and BMI	weight, waist circumference,BMI,body fat	3~5 years