Back to resultsA Clinical Study to Evaluate the Effects of Akkermansia Muciniphila on Insulin Resistance Among Obese Subjects.
Primary Purpose
Obesity Associated Disorder
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Treatment with Akkermansia muciniphila
Treatment with placebo
Sponsored by
About this trial
This is an interventional other trial for Obesity Associated Disorder focused on measuring Akkermania muciniphila, obesity, insulin resistance, metabolism, fecal flora
Eligibility Criteria
Inclusion Criteria: Aged 18-65 Overweight/obesity (24.0≤BMI≤40.0 kg/m^2) Subjects rated as insulin resistant based on homeostasis model (HOMA) 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. 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: 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)； Subjects who need or are using hypoglycemic drugs (including insulin) Subjects who are taking liver medicine Subjects who has had undergone bariatric surgery before Subjects who has Acute or chronic progressive or chronic unstable disease Subjects with Liver and kidney insufficiency, serious cardiovascular and cerebrovascular diseases Subjects with acute diabetic complications such as diabetic ketoacidosis or diabetic hypertonic coma within within latest 3 months History of intestinal or intestinal surgery within 1 year, or non-gastrointestinal surgery within 6 months Excessive alcohol consumption in the last 10 years (more than 30 g/ day for male and 20g/ day for female) Pregnant or lactating subjects Subjects that the investigator considers need to excluded due to other causes.
Sites / Locations
- The Seventh Affiliated Hospital of Southern Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
low-dose Akkermansia muciniphila group
high-dose Akkermansia muciniphila group
Placebo group
Arm Description
They were treated with one bag of test drugs (one bag each time, twice a day, for 12 weeks)
They were treated with one bag of test drugs (one bag each time, twice a day, for 12 weeks)
They were treated with one bag of test drugs (one bag each time, twice a day, for 12 weeks)
Outcomes
Primary Outcome Measures
Weight after 12weeks
Change from baseline in weight
HOMA-IR after 12weeks
Change from baseline in HOMA-IR
Secondary Outcome Measures
HbA1c after 12weeks
Change from baseline in HbA1c
Fasting and OGTT 2h blood glucose levels after 12weeks
Change from baseline in Fasting and OGTT 2h blood glucose levels
Fasting and OGTT 2h insulin and C-peptide levels after 12weeks
Change from baseline in Fasting and OGTT 2h insulin and C-peptide levels
BMI, waist circumference, waist-to-hip ratio after 12weeks
Change from baseline in BMI, waist circumference, waist-to-hip ratio
Total body fat and visceral adipose tissue after 12weeks
Change from baseline in Total body fat and visceral adipose tissue
Blood lipid profile after 12weeks
Change from baseline in Blood lipid profile(include Triglycerides, total cholesterol, LDL-c, HDL-c)
Liver enzyme after 12weeks
Change from baseline in Liver enzyme(include AST、ALT、GGT)
Fibroscan CAP after 12weeks
Change from baseline in Fibroscan CAP
Incidence and severity of TEAE and SAE
Clinical significant Vital signs, physical and laboratory results
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05720299
Brief Title
A Clinical Study to Evaluate the Effects of Akkermansia Muciniphila on Insulin Resistance Among Obese Subjects.
Official Title
A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effects of Akkermansia Muciniphila on Insulin Resistance Among Obese Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yu Chen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity Associated Disorder
Keywords
Akkermania muciniphila, obesity, insulin resistance, metabolism, fecal flora
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low-dose Akkermansia muciniphila group
Arm Type
Experimental
Arm Description
They were treated with one bag of test drugs (one bag each time, twice a day, for 12 weeks)
Arm Title
high-dose Akkermansia muciniphila group
Arm Type
Experimental
Arm Description
They were treated with one bag of test drugs (one bag each time, twice a day, for 12 weeks)
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
They were treated with one bag of test drugs (one bag each time, twice a day, for 12 weeks)
Intervention Type
Drug
Intervention Name(s)
Treatment with Akkermansia muciniphila
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment with placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight after 12weeks
Description
Change from baseline in weight
Time Frame
Baseline , Day84
Title
HOMA-IR after 12weeks
Description
Change from baseline in HOMA-IR
Time Frame
Baseline , Day84
Secondary Outcome Measure Information:
Title
HbA1c after 12weeks
Description
Change from baseline in HbA1c
Time Frame
Baseline , Day84
Title
Fasting and OGTT 2h blood glucose levels after 12weeks
Description
Change from baseline in Fasting and OGTT 2h blood glucose levels
Time Frame
Baseline , Day84
Title
Fasting and OGTT 2h insulin and C-peptide levels after 12weeks
Description
Change from baseline in Fasting and OGTT 2h insulin and C-peptide levels
Time Frame
Baseline , Day84
Title
BMI, waist circumference, waist-to-hip ratio after 12weeks
Description
Change from baseline in BMI, waist circumference, waist-to-hip ratio
Time Frame
Baseline , Day84
Title
Total body fat and visceral adipose tissue after 12weeks
Description
Change from baseline in Total body fat and visceral adipose tissue
Time Frame
Baseline , Day84
Title
Blood lipid profile after 12weeks
Description
Change from baseline in Blood lipid profile(include Triglycerides, total cholesterol, LDL-c, HDL-c)
Time Frame
Baseline , Day84
Title
Liver enzyme after 12weeks
Description
Change from baseline in Liver enzyme(include AST、ALT、GGT)
Time Frame
Baseline , Day84
Title
Fibroscan CAP after 12weeks
Description
Change from baseline in Fibroscan CAP
Time Frame
Baseline , Day84
Title
Incidence and severity of TEAE and SAE
Description
Clinical significant Vital signs, physical and laboratory results
Time Frame
Up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 18-65
Overweight/obesity (24.0≤BMI≤40.0 kg/m^2)
Subjects rated as insulin resistant based on homeostasis model (HOMA)
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.
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:
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)；
Subjects who need or are using hypoglycemic drugs (including insulin)
Subjects who are taking liver medicine
Subjects who has had undergone bariatric surgery before
Subjects who has Acute or chronic progressive or chronic unstable disease
Subjects with Liver and kidney insufficiency, serious cardiovascular and cerebrovascular diseases
Subjects with acute diabetic complications such as diabetic ketoacidosis or diabetic hypertonic coma within within latest 3 months
History of intestinal or intestinal surgery within 1 year, or non-gastrointestinal surgery within 6 months
Excessive alcohol consumption in the last 10 years (more than 30 g/ day for male and 20g/ day for female)
Pregnant or lactating subjects
Subjects that the investigator considers need to excluded due to other causes.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Chen, Doctor
Phone
+86-13824482875
Email
askasky@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Chen, Doctor
Organizational Affiliation
The Seventh Affiliated Hospital of Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Seventh Affiliated Hospital of Southern Medical University
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
514500
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Chen, doctor
Phone
+86-13824482875
Email
askasky@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
In order to protect the privacy and security of the subject, the subject data will not be provided to other researchers
Learn more about this trial
A Clinical Study to Evaluate the Effects of Akkermansia Muciniphila on Insulin Resistance Among Obese Subjects.
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