A Clinical Study to Evaluate the Effects of Akkermansia Muciniphila and Berberine on Prediabetes Among Obese Subjects.

Launched by YU CHEN · Feb 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Akkermansia muciniphila to see how it affects insulin resistance in people who are obese. Insulin resistance is when the body doesn’t respond well to insulin, which can lead to health issues. The study involves 120 participants aged 18 to 65 who have a body mass index (BMI) between 24 and 40, indicating that they are overweight or obese. To participate, individuals should not have certain health conditions, such as diabetes or serious heart disease, and they must agree to use effective birth control if they are of childbearing age.

Participants will be randomly assigned to one of three groups: one will receive a high dose of the treatment, another will receive a low dose, and the last will receive a placebo (a substance with no active treatment). The study lasts for 12 weeks, during which researchers will monitor changes in body fat, blood sugar, and other important health markers. This trial aims to determine if Akkermansia muciniphila is safe and effective in improving insulin resistance, which could help in managing obesity-related health problems.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18-65
• • 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:
• • 1. Subjects who diagnosed with diabetes mellitus, medical obesity (excluding those who have been off medication for more than 1 year), or other secondary diabetes mellitus (e.g., Cushing's syndrome, thyroid dysfunction, or acromegaly);
• • 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.