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:
Participant gender:
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.