Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05720299
Status:
RECRUITING
Last Update Posted:
2023-04-18
First Post:
2022-11-07
Brief Title:
A Clinical Study to Evaluate the Effects of Akkermansia Muciniphila on Insulin Resistance Among Obese Subjects
Sponsor:
Yu Chen
Organization:
The Seventh Affiliated Hospital Southern Medical University
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Clinical Study to Evaluate the Effects of Akkermansia Muciniphila on Insulin Resistance Among Obese Subjects
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 111 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-6IL-8IL-1 β Level plasma LPS level oxygenhydrogenmethane 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
Detailed 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 111 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-6IL-8IL-1 β Level plasma LPS level oxygenhydrogenmethane 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
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 111 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-6IL-8IL-1 β Level plasma LPS level oxygenhydrogenmethane 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None