Effect of Probiotics on Pre-diabetes and Diabetes in China

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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Biological: probiotics; Biological: placebo

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 Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400030
      • Recruiting
      • health management center,Southwest hospital
      • Contact: Ya lan zhang, MD; Phone Number: 13594348611; Email: 281072454@qq.com
      • Contact: xiao lan zhao, MD; Phone Number: 13608303976; Email: zhaoxiaolan65@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: probiotics on type 2 diabetes; take probiotics	Biological: probiotics; the probiotics group was taking probiotics 4 packets a day
Experimental: probiotics on pre-diabetes; take probiotics	Biological: probiotics; the probiotics group was taking probiotics 4 packets a day
Placebo Comparator: placebo on type 2 diabetes; take placebo	Biological: placebo; the placebo group was taking placebo 4 packets a day
Placebo Comparator: placebo on pre-diabetes; take placebo	Biological: placebo; the placebo group was taking placebo 4 packets a day

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Intestinal endocrine function	Blood GLP-1	3~5 years

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Principal Investigator: Qiang Zeng, MD, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 21, 2017
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): August 31, 2019

Study Registration Dates

• First Submitted: December 10, 2017
• First Submitted That Met QC Criteria: December 16, 2017
• First Posted (Actual): December 19, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 16, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: pre-diabetes,diabetes,probiotics
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: CHPF2017019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No