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Clinical Trial Details

Trial ID: L5331
Source ID: NCT04797442
Associated Drug: Wst01 Strain Product
Title: Effect of Akkermansia Muciniphila WST01 Strain in Overweight or Obese Patients With Type 2 Diabetes
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Obese|Overweight|Type 2 Diabetes
Interventions: DRUG: WST01 strain product|DRUG: placebo powder
Outcome Measures: Primary: Body weight, change of body weight from baseline, 12 weeks|Fasting plasma glucose levels, change of fasting plasma glucose from baseline, 12 weeks | Secondary: Gut microbiome, including fecal intestinal flora metagenome, 12 weeks|Glycated haemoglobin (HbA1c), 12 weeks|2-hour post-prandial plasma glucose levels, 12 weeks|Fasting serum insulin levels, 12 weeks|2-hour post-prandial serum insulin levels, 12 weeks|Fasting glucagon-like peptide-1 (GLP-1) levels, 12 weeks|2-hour post-prandial GLP-1 levels, 12 weeks|Serum triglycerides, 12 weeks|Serum total cholesterol, 12 weeks|Serum LDL-c, 12 weeks|Serum HDL-c, 12 weeks|Area of visceral and subcutaneous fat, 12 weeks|Waist and hip circumference, 12 weeks|Energy expenditure, using metabolic chamber to measure energy expenditure, 12 weeks|Blood metabolomics profile measurement, In aid of LC/MS and GC/MS technique, etc, 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, etc. The composition change of all these biological molecular induced by the treatment is our major interest rather than single molecular quantification., 12 weeks|Inflammation markers, including hs-CRP, TNF-alfa, IL-6, and IL-8, etc, 12 weeks|Systolic and diastolic blood pressure, Safety outcomes, 12 weeks|Body temperature, Safety outcomes, 12 weeks|Pulse rate, Safety outcomes, 12 weeks|White blood cell (WBC) count, Safety outcomes, 12 weeks|Red blood cell (RBC) count, Safety outcomes, 12 weeks|Hemoglobin levels, Safety outcomes, 12 weeks|Platelet count, Safety outcomes, 12 weeks|Hepatic function, including alanine aminotransferase, aspartate aminotransferase,ɣ-glutamyltransferase, and alkaline phosphatase, 12 weeks|Renal function, including serum urea nitrogen, serum creatinine, and serum urinary acid, 12 weeks|Adverse events, Safety outcomes, 12 weeks|Fasting serum C peptide levels, 12 weeks|2-hour post-prandial serum C peptide levels, 12 weeks|Lean mass, using DEXA scan to measure lean mass, 12 weeks|Fat mass, using DEXA scan to measure fat mass, 12 weeks
Sponsor/Collaborators: Sponsor: Shanghai Jiao Tong University School of Medicine
Gender: ALL
Age: ADULT
Phases: PHASE2
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2021-07-15
Completion Date: 2024-03-31
Results First Posted:
Last Update Posted: 2023-10-17
Locations: Dep.endocrinology of Shanghai Ruijin Hospital, Shanghai Jiaotong university school of medcine, Shanghai, Shanghai, 200025, China
URL: https://clinicaltrials.gov/show/NCT04797442