Status:
UNKNOWN
Effect of Akkermansia Muciniphila WST01 Strain in Overweight or Obese Patients With Type 2 Diabetes
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Obese
Overweight
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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) int...
Eligibility Criteria
Inclusion
- Main
- 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.
- Main
Exclusion
- 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.
Key Trial Info
Start Date :
July 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04797442
Start Date
July 15 2021
End Date
March 31 2024
Last Update
October 17 2023
Active Locations (1)
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1
Dep.endocrinology of Shanghai Ruijin Hospital, Shanghai Jiaotong university school of medcine
Shanghai, Shanghai Municipality, China, 200025