A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Effect of Akkermansia Muciniphila WST01 Strain in Patients With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fasting plasma glucose levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with type 2 diabetes mellitus;
- •Age 18-60 years;
- •Overweight / obesity (24.0 ≤ BMI ≤ 40.0 kg/m2)；
- •Subjects with or without other obesity related metabolic complications (hypertension, dyslipidemia, hyperuricemia, etc.);
- •Subjects with screening HbA1c ≥ 7.0% and ≤ 10.0%, and the fasting blood glucose ≥ 7.0 mmol/l and ≤ 13.3 mmol/l；
- •Subjects who are not taking any medications to control blood glucose;
- •Subjects control blood glucose only by lifestyle intervention (diet and exercise) for at least 2 months before the screening period;
- •Subjects understand the nature, significance, potential benefits, inconvenience, and risks of the study before it starts；
- •Subjects fully understand the study produces and voluntarily sign the informed consent form.
排除标准
- •Subjects with a history of taking hypoglycemic drugs;
- •Subjects who are pregnant or in lactation;
- •Subjects with type 1 diabetes, single gene mutation diabetes, diabetes due to pancreatic injury or other secondary diabetes (such as Cushing's syndrome, thyroid dysfunction or acromegaly, etc.);
- •Subjects who were or are using oral hypoglycemic agents or insulin or incretin to control diabetes;
- •Subjects with liver and kidney dysfunction (alanine transaminase(ALT) / aspartate aminotransferase(AST)≥2.5×the upper limit of normal(ULN) set by the hospital, serum creatinine>1×ULN set by the hospital, or eGFR<60mL/min/1.73m2);
- •Surgery with serious cardiovascular and cerebrovascular diseases (such as heart failure, myocardial infarction, cerebral infarction, acute myocarditis, severe arrhythmia, patients receiving interventional therapy, etc.) or stage III hypertension (systolic blood pressure cannot be controlled below 160 mmHg with three antihypertensive drugs);
- •Subjects with acute diabetic complications such as diabetic ketoacidosis or diabetic hyperosmolar coma in the past 3 months;
- •Subjects with a medical history of malignant tumor (except local skin basal cell carcinoma) in the past 5 years;
- •Subjects with a medical history of intestine, or other digestive tract surgery (such as cholecystectomy) within one year, or other non-gastrointestinal surgery within 6 months;
- •Any condition that in the judgement of the investigator precludes participation.
- •Details please see the study protocol.
研究组 & 干预措施
Experimental
干预措施: WST01 strain product (Drug)
Placebo comparator
干预措施: placebo powder (Drug)
结局指标
主要结局
Fasting plasma glucose levels
时间窗: 12 weeks
change of fasting plasma glucose from baseline
Body weight
时间窗: 12 weeks
change of body weight from baseline
次要结局
- Red blood cell (RBC) count(12 weeks)
- Serum HDL-c(12 weeks)
- Energy expenditure(12 weeks)
- Inflammation markers(12 weeks)
- Systolic and diastolic blood pressure(12 weeks)
- Body temperature(12 weeks)
- Hepatic function(12 weeks)
- Blood metabolomics profile measurement(12 weeks)
- Pulse rate(12 weeks)
- Fat mass(12 weeks)
- 2-hour post-prandial plasma glucose levels(12 weeks)
- 2-hour post-prandial GLP-1 levels(12 weeks)
- Serum triglycerides(12 weeks)
- Area of visceral and subcutaneous fat(12 weeks)
- Gut microbiome(12 weeks)
- Fasting serum insulin levels(12 weeks)
- Serum LDL-c(12 weeks)
- 2-hour post-prandial serum C peptide levels(12 weeks)
- Glycated haemoglobin (HbA1c)(12 weeks)
- Fasting glucagon-like peptide-1 (GLP-1) levels(12 weeks)
- Renal function(12 weeks)
- Adverse events(12 weeks)
- 2-hour post-prandial serum insulin levels(12 weeks)
- Serum total cholesterol(12 weeks)
- Waist and hip circumference(12 weeks)
- White blood cell (WBC) count(12 weeks)
- Hemoglobin levels(12 weeks)
- Platelet count(12 weeks)
- Fasting serum C peptide levels(12 weeks)
- Lean mass(12 weeks)
研究者
Wang Weiqing
Professor, PHD, MD
Shanghai Jiao Tong University School of Medicine