Clinical Trial Details
| Trial ID: | L6505 |
| Source ID: | NCT02861261 |
| Associated Drug: | 1. Berberine Hydrochloride Tablets ; 2. Promets Probiotics Powder |
| Title: | A Study on the Efficacy and Gut Microbiota of Berberine and Probiotics in Patients With Newly Diagnosed Type 2 Diabetes |
| Acronym: | |
| Status: | UNKNOWN |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes |
| Interventions: | DRUG: 1. Berberine hydrochloride tablets ; 2. ProMetS probiotics powder|DRUG: 1. Berberine placebo tablets ; 2. ProMetS probiotics powder|DRUG: 1. Berberine hydrochloride tablets; 2. Probiotics placebo powder|DRUG: 1. Berberine placebo tablets; 2. Probiotics placebo powder |
| Outcome Measures: | Primary: HbA1c, 13 weeks | Secondary: Gut microbiome, 13 weeks|Fasting glucose levels, 13 weeks|2-hour postprandial glucose levels, 13 weeks|Fasting insulin levels, 13 weeks|2-hour postprandial insulin levels, 13 weeks|Serum Triglycerides, 13 weeks|Serum total Cholesterol, 13 weeks|Serum HDL-c, 13 weeks|Serum LDL-c, 13 weeks|Blood metabolomics profile measurement, In aid of LC/MS and GC/MS technique, we will measure the metabolomics molecular profile in blood samples before and after treatment. The metabolomics measurement will help to detect the profile of all kinds of bile acid species, lipids species and amino acid species. The composition change of all these biological molecular induced by the treatment is our major interest rather than single molecular quantification, 13 weeks|Blood Incretin, In aid of multiple ELISA based on xMAP Luminex technology, we will measure gut hormones, including Glp-1, GIP and PYY in ng/ml., 13 weeks|Inflammation markers (hs-CRP, TNF-alfa, IL-6, and IL-8 etc. in ng/ml), 13 weeks |
| Sponsor/Collaborators: | Sponsor: Shanghai Jiao Tong University School of Medicine |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 400 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2016-08-18 |
| Completion Date: | 2019-05 |
| Results First Posted: | |
| Last Update Posted: | 2019-02-12 |
| Locations: | Ruijin hospital,Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China |
| URL: | https://clinicaltrials.gov/show/NCT02861261 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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