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

NCT ID: NCT04797442

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-15
• Study Completion Date: 2024-03-31

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 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.

Conditions

Obese; Overweight; Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental

Group Type: EXPERIMENTAL

WST01 strain product

Intervention Type: DRUG

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)

Placebo comparator

Group Type: PLACEBO_COMPARATOR

placebo powder

Intervention Type: DRUG

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)

Interventions

WST01 strain product

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)

Intervention Type: DRUG

placebo powder

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)

Intervention Type: DRUG

Eligibility Criteria

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.

Details please see the study protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Wang Weiqing

Professor, PHD, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Shanghai, Shanghai Municipality, China

Countries

China

References

Zhang Y, Liu R, Chen Y, Cao Z, Liu C, Bao R, Wang Y, Huang S, Pan S, Qin L, Wang J, Ning G, Wang W. Akkermansia muciniphila supplementation in patients with overweight/obese type 2 diabetes: Efficacy depends on its baseline levels in the gut. Cell Metab. 2025 Mar 4;37(3):592-605.e6. doi: 10.1016/j.cmet.2024.12.010. Epub 2025 Jan 28.

Reference Type: DERIVED

PMID: 39879980 (View on PubMed)

Other Identifiers

WST001

Identifier Type: -

Identifier Source: org_study_id