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

Yu Chen

Status: Completed

Conditions: Prediabetes

Treatments: Drug: Berberine; Drug: Akkermansia muciniphila; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05720299

ZY19-202201

Details and patient eligibility

About

The Akkermania muciniphila may play an important role in the occurrence and development of Prediabetes. The purpose of this study was to evaluate the safety and efficacy of AKK in the treatment of Prediabetes among obese patients. In this study, a single center, randomized, double-blind, placebo-controlled design is adopted. 90 obese subjects with Prediabetes are included in this study, and are allocated to AKK group, BBR group, and placebo group at a ratio of 1:1:1. The study treatment lasts for 12 weeks. The changes of body fat, glucose metabolism, lipid metabolism indicators compared with the baseline at the end of the treatment will be analyzed. In addition, glucagon like peptide-1 (GLP-1) and inflammatory markers (hsCRP、TNF-α、IL-6、IL-8、IL-1β) in blood will be analyzed before and after treatment. The changes in fecal flora structure and the AKK bacteria also will be analyzed.

Enrollment: 110 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 3 patient groups, including a placebo group

Akkermansia muciniphila group(AKK)

Experimental group

Description:

They will be treated with one tablet of AKK, twice a day, for 12 weeks.

Treatment:

Drug: Akkermansia muciniphila

Berberine group

Experimental group

Description:

They will be treated with one tablet of Berberine, twice a day, for 12 weeks.

Treatment:

Drug: Berberine

Placebo group

Placebo Comparator group

Description:

They will be treated with one tablet of placebo, twice a day, for 12 weeks.

Treatment:

Drug: Placebo