Obesity Associated Disorder Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effects of Akkermansia Muciniphila on Insulin Resistance Among Obese Subjects.
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03615534 -
Extended Release Niacin and Fenofibrate for the Treatment of Atherogenic Dyslipidemia in Obese Females
|
Phase 4 | |
Recruiting |
NCT04926714 -
Ophthalmologic Evaluation of Patients With Obesity and Metabolic Syndrome Before and After Bariatric Surgery
|
||
Recruiting |
NCT06001632 -
Changes in Muscle Strength, Inflammatory Markers, and Body Composition in Response to Alternate Day Fasting Combined With Krill Oil Supplementation in Adults With Overweight and Obesity
|
N/A | |
Completed |
NCT03983135 -
Revisional Bariatric Surgery Experience
|
N/A | |
Enrolling by invitation |
NCT05725967 -
Endoscopic Metabolic and Bariatric Therapies
|
||
Active, not recruiting |
NCT05645926 -
Association of Obesity and Cardiovascular Outcomes in Myocardial Infarction
|
||
Completed |
NCT06071559 -
Bariatric Surgery on obesity-and Diabetes-associated Abnormalities of Hemostasis, Inflammation and Vascular Function.
|
N/A | |
Completed |
NCT05101395 -
Prevalence of H. Pylori Gastritis in Sleeve Gastrectomy Specimens
|
||
Completed |
NCT05790317 -
Comparison of the Effect of Traditional Method and Eras Protocol in Obesity Surgery
|
N/A | |
Recruiting |
NCT06236932 -
Susceptibility to Infectious Diseases in obEsity: an endocRine trAnslational socioLogic Evaluation, "SIDERALE"
|
N/A | |
Completed |
NCT05508997 -
Respiratory and Hemodynamics Parameters Response to Positive End-Expiratory Pressure
|
N/A | |
Completed |
NCT04799665 -
Dedicated Breast CT for Quantitative Breast Density Measurements in Mexican-origin Women in Southern Arizona
|