A Clinical Study to Evaluate the Effects of Akkermansia Muciniphila and Berberine on Prediabetes Among Obese Subjects.
NCT ID: NCT05720299
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2025-03-12
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Akkermansia muciniphila group(AKK)
They will be treated with one tablet of AKK, twice a day, for 12 weeks.
Akkermansia muciniphila
one tablet of AKK
Berberine group
They will be treated with one tablet of Berberine, twice a day, for 12 weeks.
Berberine
one tablet of Berberine
Placebo group
They will be treated with one tablet of placebo, twice a day, for 12 weeks.
Placebo
one tablet of placebo
Interventions
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Akkermansia muciniphila
one tablet of AKK
Berberine
one tablet of Berberine
Placebo
one tablet of placebo
Eligibility Criteria
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Inclusion Criteria
2. Overweight/obesity (24.0≤BMI≤40.0 kg/m\^2)
3. Fasting blood glucose ≥6.1 and \<7.0 mmol/L, or 2-hour postprandial blood glucose ≥7.8 and \<11.1 mmol/L, or glycosylated hemoglobin ≥5.7% and \<6.5%
4. Fertile subjects (including male and female subjects) agreed to take effective contraceptive measures that the investigator accepted during and within 3 months after the trial (e.g. intrauterine device or a condom); the fertile female subjects with serum human chorionic gonadotropin test negative results within 7 days before the investigational product administration; Infertile female must be surgically infertile or at least 1 year after menopause.
5. Subjects should understand the nature, significance, potential benefits, inconvenience and risks of the study before the trial begins, fully understand and voluntarily sign the informed consent.
Exclusion Criteria
2. Subjects who has undergone bariatric surgery;
3. Subjects who has acute or chronic progressive or unstable disease, liver and kidney insufficiency, serious cardiovascular and cerebrovascular diseases;
3.Subjects with acute diabetic complications such as diabetic ketoacidosis or diabetic hypertonic coma within within latest 3 months; 4.Patients with hemolytic anemia or glucose-6-phosphate dehydrogenase deficiency; 5.History of intestinal or intestinal surgery within 1 year, or non-gastrointestinal surgery within 6 months; 6.Excessive alcohol consumption in the last 10 years (more than 30 g/ day for male and 20g/ day for female) 7.Pregnant or lactating subjects 8.Subjects that the investigator considers need to excluded due to other causes.
18 Years
65 Years
ALL
No
Sponsors
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Yu Chen
OTHER
Responsible Party
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Yu Chen
Chief of Department of Gastroenterology
Principal Investigators
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Yu Chen, Doctor
Role: PRINCIPAL_INVESTIGATOR
The Seventh Affiliated Hospital of Southern Medical University
Locations
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The Seventh Affiliated Hospital of Southern Medical University
Foshan, Guangdong, China
Countries
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Other Identifiers
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ZY19-202201
Identifier Type: -
Identifier Source: org_study_id