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Clinical Trial Details

Trial ID: L5844
Source ID: NCT04287387
Associated Drug: Glucophage 500mg Tablet
Title: Response of Gut Microbiota in Type 2 Diabetes to Hypoglycemic Agents
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type2 Diabetes Mellitus
Interventions: DRUG: Glucophage 500Mg Tablet|DRUG: Acarbose Tablets|DRUG: Sitagliptin tablet|DRUG: Dapagliflozin Tablet|DRUG: Pioglitazone Tablets|DRUG: Glimepiride Tablets
Outcome Measures: Primary: Changes from baseline to post-treatment in composition in gut microbiota analyzed by meta-genome sequencing., Baseline, Week 4, Week 8, Week 12|Changes from baseline to post-treatment in composition in fasting blood glucose., Baseline, Week 4, Week 8, Week 12|Changes from baseline to post-treatment in composition in level of TNF-a., Baseline, Week 4, Week 8, Week 12|Changes from baseline to post-treatment in composition in fasting insulin., Baseline, Week 4, Week 8, Week 12|Changes from baseline to post-treatment in blood lipid including cholesterol, triglycerides, high-density lipoprotein., Baseline, Week 4, Week 8, Week 12|Changes from baseline to post-treatment in composition in 2-hour postprandial blood glucose., Baseline, Week 4, Week 8, Week 12|Changes from baseline to post-treatment in composition in level of IL-6., Baseline, Week 4, Week 8, Week 12|Changes from baseline to post-treatment in composition in level of IL-8., Baseline, Week 4, Week 8, Week 12|Changes from baseline to post-treatment in composition in level of IL-10., Baseline, Week 4, Week 8, Week 12|Changes from baseline to post-treatment in composition in level of C-reative protein., Baseline, Week 4, Week 8, Week 12 | Secondary: The linear relationship between gut microbiota and blood glucose and blood lipid level., Week 4, Week 8, Week 12|The linear relationship between gut microbiota and inflammation factors level., Week 4, Week 8, Week 12
Sponsor/Collaborators: Sponsor: Peking Union Medical College Hospital | Collaborators: Chinese Academy of Sciences
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 180
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-03-02
Completion Date: 2021-03-02
Results First Posted:
Last Update Posted: 2020-02-27
Locations: Peking Union Medical College Hospital, Beijing, Beijing, 100730, China
URL: https://clinicaltrials.gov/show/NCT04287387