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Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05720299
Study type Interventional
Source The Seventh Affiliated Hospital, Southern Medical University
Contact Yu Chen, Doctor
Phone +86-13824482875
Email askasky@126.com
Status Recruiting
Phase N/A
Start date March 29, 2023
Completion date December 31, 2024

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