| Trial ID: | L2801 |
| Source ID: | NCT02084004
|
| Associated Drug: |
Bifidobacterium Viable Pharmaceutics
|
| Title: |
Effects of Berberine Hydrochloride and Bifidobacterium in Diabetes Mellitus Prevention and Treatment
|
| Acronym: |
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Bifidobacterium viable pharmaceutics|DRUG: Berberine Hydrochloride
|
| Outcome Measures: |
Primary: Change in HbA1c from baseline to week 12, Change was measured at baseline and week 12 after randomization. Change was reported as the absolute difference in % HbA1c., Baseline and week 12 | Secondary: Percentage of subjects achieving HbA1c < 7% at week 12, Week 12|Gut microbiome composition, Faecal bacterial composition determined from microbiological cultures and deep metagenomic next-generation sequencing of bacterial DNA in feces., Baseline and week 12|Changes in postprandial glucagon-like peptide-1 (GLP-1) secretion between baseline and week 12, Plasma level of GLP-1 at baseline and week 12 during a 2 hour-meal test., Baseline and week 12|Adverse effects, Standardized questionaries regarding gastrointestinal function are filled out at each study visit (0, 4, 8 and 12 weeks after randomization) to detect possible adverse effects of antibiotics. In addition, subjects are given a calendar and informed to write down any symptom or illness during the study period., From baseline to week 12
|
| Sponsor/Collaborators: |
Sponsor: Xijing Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2015-11
|
| Completion Date: |
2018-04
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| Results First Posted: |
|
| Last Update Posted: |
2018-11-14
|
| Locations: |
Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710004, China|The 323rd Hospital of People's Liberation Army, Xi'an, Shaanxi, 710054, China|First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, 710061, China|Shaanxi Provincial People's Hospital, Xi'an, Shaanxi, 710068, China
|
| URL: |
https://clinicaltrials.gov/show/NCT02084004
|
