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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05720299
Other study ID # ZY19-202201
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 29, 2023
Est. completion date December 31, 2024

Study information

Verified date April 2023
Source The Seventh Affiliated Hospital, Southern Medical University
Contact Yu Chen, Doctor
Phone +86-13824482875
Email askasky@126.com
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Treatment with Akkermansia muciniphila
120 subjects were randomly assigned to ZY19 low-dose group, ZY19 high-dose group and placebo group at a ratio of 1:1:1. They were treated with one bag of test drugs (one bag each time, twice a day, for 12 weeks) in ZY19 low-dose group, ZY19 high-dose group and placebo group respectively.
Other:
Treatment with placebo
120 subjects were randomly assigned to ZY19 low-dose group, ZY19 high-dose group and placebo group at a ratio of 1:1:1. They were treated with one bag of test drugs (one bag each time, twice a day, for 12 weeks) in ZY19 low-dose group, ZY19 high-dose group and placebo group respectively.

Locations

Country Name City State
China The Seventh Affiliated Hospital of Southern Medical University Foshan Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Yu Chen

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight after 12weeks Change from baseline in weight Baseline , Day84
Primary HOMA-IR after 12weeks Change from baseline in HOMA-IR Baseline , Day84
Secondary HbA1c after 12weeks Change from baseline in HbA1c Baseline , Day84
Secondary Fasting and OGTT 2h blood glucose levels after 12weeks Change from baseline in Fasting and OGTT 2h blood glucose levels Baseline , Day84
Secondary Fasting and OGTT 2h insulin and C-peptide levels after 12weeks Change from baseline in Fasting and OGTT 2h insulin and C-peptide levels Baseline , Day84
Secondary BMI, waist circumference, waist-to-hip ratio after 12weeks Change from baseline in BMI, waist circumference, waist-to-hip ratio Baseline , Day84
Secondary Total body fat and visceral adipose tissue after 12weeks Change from baseline in Total body fat and visceral adipose tissue Baseline , Day84
Secondary Blood lipid profile after 12weeks Change from baseline in Blood lipid profile(include Triglycerides, total cholesterol, LDL-c, HDL-c) Baseline , Day84
Secondary Liver enzyme after 12weeks Change from baseline in Liver enzyme(include AST?ALT?GGT) Baseline , Day84
Secondary Fibroscan CAP after 12weeks Change from baseline in Fibroscan CAP Baseline , Day84
Secondary Incidence and severity of TEAE and SAE Clinical significant Vital signs, physical and laboratory results Up to 12 weeks
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