Phase
Condition
Diabetes (Pediatric)
Diabetes And Hypertension
Diabetes Prevention
Treatment
Berberine
AKK Placebo
Akkermansia muciniphila
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged 18-65
Overweight/obesity (24.0≤BMI≤40.0 kg/m^2)
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%
Fertile subjects (including male and female subjects) agreed to take effectivecontraceptive measures that the investigator accepted during and within 3 monthsafter the trial (e.g. intrauterine device or a condom); the fertile female subjectswith serum human chorionic gonadotropin test negative results within 7 days beforethe investigational product administration; Infertile female must be surgicallyinfertile or at least 1 year after menopause.
Subjects should understand the nature, significance, potential benefits,inconvenience and risks of the study before the trial begins, fully understand andvoluntarily sign the informed consent.
Exclusion
Exclusion Criteria:
Subjects who diagnosed with diabetes mellitus, medical obesity (excluding those whohave been off medication for more than 1 year), or other secondary diabetes mellitus (e.g., Cushing's syndrome, thyroid dysfunction, or acromegaly);
Subjects who has undergone bariatric surgery;
Subjects who has acute or chronic progressive or unstable disease, liver and kidneyinsufficiency, 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.
Study Design
Connect with a study center
The Seventh Affiliated Hospital of Southern Medical University
Foshan, Guangdong 514500
ChinaActive - Recruiting

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