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Effect of Akkermansia Muciniphila WST01 Strain in Overweight or Obese Patients With Type 2 Diabetes

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial to Evaluate the Effect of Akkermansia Muciniphila WST01 Strain in Patients With Type 2 Diabetes

NCT04797442•Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

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 WST01 strain in overweight or obese patients with Type 2 Diabetes.

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) 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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects with type 2 diabetes mellitus;
•2. Age 18-60 years;
•3. Overweight / obesity (24.0 ≤ BMI ≤ 40.0 kg/m2)；
•4. Subjects with or without other obesity related metabolic complications (hypertension, dyslipidemia, hyperuricemia, etc.);
•5. Subjects with screening HbA1c ≥ 7.0% and ≤ 10.0%, and the fasting blood glucose ≥ 7.0 mmol/l and ≤ 13.3 mmol/l；
•6. Subjects who are not taking any medications to control blood glucose;
•7. Subjects control blood glucose only by lifestyle intervention (diet and exercise) for at least 2 months before the screening period;
•8. Subjects understand the nature, significance, potential benefits, inconvenience, and risks of the study before it starts；
•9. Subjects fully understand the study produces and voluntarily sign the informed consent form.

Exclusion Criteria

•1. Subjects with a history of taking hypoglycemic drugs;
•2. Subjects who are pregnant or in lactation;
•3. 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.);
•4. Subjects who were or are using oral hypoglycemic agents or insulin or incretin to control diabetes;
•5. 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);
•6. 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);
•7. Subjects with acute diabetic complications such as diabetic ketoacidosis or diabetic hyperosmolar coma in the past 3 months;
•8. Subjects with a medical history of malignant tumor (except local skin basal cell carcinoma) in the past 5 years;
•9. 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;
•10. Any condition that in the judgement of the investigator precludes participation.
+1 more criteria

Locations (1)

Dep.endocrinology of Shanghai Ruijin Hospital, Shanghai Jiaotong university school of medcine

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

July 15, 2021

Primary Completion Date

November 9, 2022

Completion Date

March 31, 2024

Last Updated

October 17, 2023

Enrollment

ESTIMATED participants

Conditions

ObeseOverweightType 2 Diabetes

Interventions

WST01 strain product

DRUG

placebo powder

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 17, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effect of Akkermansia Muciniphila WST01 Strain in Overweight or Obese Patients With Type 2 Diabetes

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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