Trials / Unknown
UnknownNCT03377946
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- Sponsor
- Chinese PLA General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | probiotics | the probiotics group was taking probiotics 4 packets a day |
| BIOLOGICAL | placebo | the placebo group was taking placebo 4 packets a day |
Timeline
- Start date
- 2017-12-21
- Primary completion
- 2018-12-31
- Completion
- 2019-08-31
- First posted
- 2017-12-19
- Last updated
- 2017-12-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03377946. Inclusion in this directory is not an endorsement.