The purpose of this study is to conduct a randomized, double-blinded, placebo-controlled, multicenter clinical trial, evaluating the glucose-lowering and weight-loss effects of Akkermansia muciniphila WST01 strain in overweight or obese patients with Type 2 Diabetes.
In the present study, about 60 overweight/obese and drug naïve type 2 diabetes patients will be enrolled from multiple centers in China. After screening, eligible subjects will be randomized (1:1) into two groups, taking either Akkermansia muciniphila WST01 strain product or placebo product for 12 weeks. Blood, feces and urine samples will be collected before and after treatment. Metabolic parameters including waist and hip circumference, area of visceral and subcutaneous fat, glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPG), insulin, glucagon-like peptide 1 (GLP-1), inflammation factors and lipid levels will be measured. Furthermore, the change of gut microbiota and metabolites will be evaluated too. The primary objective is to determine whether Akkermansia muciniphila WST01 strain has a positive effect in patients with Type 2 Diabetes. The secondary objective is to explore the effect of Akkermansia muciniphila WST01 strain on safety, intestinal flora, insulin sensitivity, and other metabolic indicators and metabolites in the patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
orally given WST01 strain product, added onto lifestyle. The specific ingredients are the optimized Akkermansia muciniphila WST01 strain powder with maximum live bacteria of 5\*10\^10 CFU/g (1 g/pack, 3 packs QD, 20-30 min after breakfast)
orally given placebo powder (the specific ingrdients are the excipients of the WST01 strain powder), added onto lifestyle. (3 packs of placebo powder QD, 20-30 min after breakfast)
Dep.endocrinology of Shanghai Ruijin Hospital, Shanghai Jiaotong university school of medcine
Shanghai, Shanghai Municipality, China
Body weight
change of body weight from baseline
Time frame: 12 weeks
Fasting plasma glucose levels
change of fasting plasma glucose from baseline
Time frame: 12 weeks
Gut microbiome
including fecal intestinal flora metagenome
Time frame: 12 weeks
Glycated haemoglobin (HbA1c)
Time frame: 12 weeks
2-hour post-prandial plasma glucose levels
Time frame: 12 weeks
Fasting serum insulin levels
Time frame: 12 weeks
2-hour post-prandial serum insulin levels
Time frame: 12 weeks
Fasting glucagon-like peptide-1 (GLP-1) levels
Time frame: 12 weeks
2-hour post-prandial GLP-1 levels
Time frame: 12 weeks
Serum triglycerides
Time frame: 12 weeks
Serum total cholesterol
Time frame: 12 weeks
Serum LDL-c
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Time frame: 12 weeks
Serum HDL-c
Time frame: 12 weeks
Area of visceral and subcutaneous fat
Time frame: 12 weeks
Waist and hip circumference
Time frame: 12 weeks
Energy expenditure
using metabolic chamber to measure energy expenditure
Time frame: 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.
Time frame: 12 weeks
Inflammation markers
including hs-CRP, TNF-alfa, IL-6, and IL-8, etc
Time frame: 12 weeks
Systolic and diastolic blood pressure
Safety outcomes
Time frame: 12 weeks
Body temperature
Safety outcomes
Time frame: 12 weeks
Pulse rate
Safety outcomes
Time frame: 12 weeks
White blood cell (WBC) count
Safety outcomes
Time frame: 12 weeks
Red blood cell (RBC) count
Safety outcomes
Time frame: 12 weeks
Hemoglobin levels
Safety outcomes
Time frame: 12 weeks
Platelet count
Safety outcomes
Time frame: 12 weeks
Hepatic function
including alanine aminotransferase, aspartate aminotransferase,ɣ-glutamyltransferase, and alkaline phosphatase
Time frame: 12 weeks
Renal function
including serum urea nitrogen, serum creatinine, and serum urinary acid
Time frame: 12 weeks
Adverse events
Safety outcomes
Time frame: 12 weeks
Fasting serum C peptide levels
Time frame: 12 weeks
2-hour post-prandial serum C peptide levels
Time frame: 12 weeks
Lean mass
using DEXA scan to measure lean mass
Time frame: 12 weeks
Fat mass
using DEXA scan to measure fat mass
Time frame: 12 weeks