Effect of Probiotics on Pre-diabetes and Diabetes in China
NCT ID: NCT03377946
Last Updated: 2017-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
220 participants
INTERVENTIONAL
2017-12-21
2019-08-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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probiotics on type 2 diabetes
take probiotics
probiotics
the probiotics group was taking probiotics 4 packets a day
probiotics on pre-diabetes
take probiotics
probiotics
the probiotics group was taking probiotics 4 packets a day
placebo on type 2 diabetes
take placebo
placebo
the placebo group was taking placebo 4 packets a day
placebo on pre-diabetes
take placebo
placebo
the placebo group was taking placebo 4 packets a day
Interventions
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probiotics
the probiotics group was taking probiotics 4 packets a day
placebo
the placebo group was taking placebo 4 packets a day
Eligibility Criteria
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Inclusion Criteria
2. BMI 18-35kg/m2
Exclusion Criteria
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
18 Years
60 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Responsible Party
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Qiang Zeng
Director of Health Management Institue
Principal Investigators
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Qiang Zeng, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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health management center,Southwest hospital
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Ya lan zhang, MD
Role: primary
xiao lan zhao, MD
Role: backup
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CHPF2017019
Identifier Type: -
Identifier Source: org_study_id