A Clinical Study to Evaluate the Effects of Akkermansia Muciniphila on Insulin Resistance Among Obese Subjects.

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

In this study, the drug Akkermania muciniphila has been proved to play an important role in the occurrence and development of obesity related metabolic diseases. The purpose of this study was to evaluate the safety and efficacy of AKK in the treatment of insulin resistance related obesity. In this study, a single center, randomized, double-blind, placebo-controlled design was adopted. 120 patients with obesity related to insulin resistance were included in this study, and were allocated to live bacteria high-dose group, live bacteria low-dose group, and placebo group at a ratio of 1:1:1. The study lasted for 12 weeks. The changes of body fat, glucose metabolism, lipid metabolism indicators, and fatty liver changes compared with the baseline at the end of the treatment were analyzed. In addition, glucagon like peptide-1 (GLP-1) in plasma and inflammatory markers (hsCRP, TNF) in blood will be analyzed before and after treatment- α、 IL-6、IL-8、IL-1 β） Level, plasma LPS level, oxygen/hydrogen/methane level in methane hydrogen breath test, changes in fecal flora structure, and the mechanism of AKK bacteria affecting insulin resistance by analyzing bacterial metabonomics molecular spectrum in plasma and urine.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yu Chen

Criteria

Inclusion Criteria:

1. Aged 18-65

2. Overweight/obesity (24.0≤BMI≤40.0 kg/m^2)

3. Subjects rated as insulin resistant based on homeostasis model (HOMA)

4. Fertility 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 fertility 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 with Type 1 diabetes 、Single gene mutation diabet,Diabetes due to pancreatic injury,Iatrogenic obesity (excluding those who have stopped medication for more than 1 year), or other secondary diabetes (such as Cushing's syndrome, thyroid dysfunction, or acromegaly)；

2. Subjects who need or are using hypoglycemic drugs (including insulin)

3. Subjects who are taking liver medicine

4. Subjects who has had undergone bariatric surgery before

5. Subjects who has Acute or chronic progressive or chronic unstable disease

6. Subjects with Liver and kidney insufficiency, serious cardiovascular and cerebrovascular diseases

7. Subjects with acute diabetic complications such as diabetic ketoacidosis or diabetic hypertonic coma within within latest 3 months

8. History of intestinal or intestinal surgery within 1 year, or non-gastrointestinal surgery within 6 months

9. Excessive alcohol consumption in the last 10 years (more than 30 g/ day for male and 20g/ day for female)

10. Pregnant or lactating subjects

11. Subjects that the investigator considers need to excluded due to other causes.