Type 2 Diabetes Mellitus
Conditions
Keywords
pre-diabetes,diabetes,probiotics
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
Interventions
BIOLOGICALprobiotics
the probiotics group was taking probiotics 4 packets a day
BIOLOGICALplacebo
the placebo group was taking placebo 4 packets a day
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes of Intestinal endocrine function | 3~5 years | Blood GLP-1 |
Countries
China
Contacts
Primary ContactFei Wang, MD
Outcome results
None listed