A Clinical Study to Evaluate the Effects of Akkermansia Muciniphila and Berberine on Prediabetes Among Obese Subjects.
- Conditions
- Prediabetes
- Interventions
- Registration Number
- NCT05720299
- Lead Sponsor
- Yu Chen
- Brief Summary
The Akkermania muciniphila may play an important role in the occurrence and development of Prediabetes. The purpose of this study was to evaluate the safety and efficacy of AKK in the treatment of Prediabetes among obese patients. In this study, a single center, randomized, double-blind, placebo-controlled design is adopted. 90 obese subjects with Prediabetes are included in this study, and are allocated to AKK group, BBR group, and placebo group at a ratio of 1:1:1. The study treatment lasts for 12 weeks. The changes of body fat, glucose metabolism, lipid metabolism indicators compared with the baseline at the end of the treatment will be analyzed. In addition, glucagon like peptide-1 (GLP-1) and inflammatory markers (hsCRP、TNF-α、IL-6、IL-8、IL-1β) in blood will be analyzed before and after treatment. The changes in fecal flora structure and the AKK bacteria also will be analyzed.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- Aged 18-65
- Overweight/obesity (24.0≤BMI≤40.0 kg/m^2)
- Fasting blood glucose ≥6.1 and <7.0 mmol/L, or 2-hour postprandial blood glucose ≥7.8 and <11.1 mmol/L, or glycosylated hemoglobin ≥5.7% and <6.5%
- Fertile 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 fertile 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.
- Subjects who diagnosed with diabetes mellitus, medical obesity (excluding those who have been off medication for more than 1 year), or other secondary diabetes mellitus (e.g., Cushing's syndrome, thyroid dysfunction, or acromegaly);
- Subjects who has undergone bariatric surgery;
- Subjects who has acute or chronic progressive or unstable disease, liver and kidney insufficiency, serious cardiovascular and cerebrovascular diseases;
3.Subjects with acute diabetic complications such as diabetic ketoacidosis or diabetic hypertonic coma within within latest 3 months; 4.Patients with hemolytic anemia or glucose-6-phosphate dehydrogenase deficiency; 5.History of intestinal or intestinal surgery within 1 year, or non-gastrointestinal surgery within 6 months; 6.Excessive alcohol consumption in the last 10 years (more than 30 g/ day for male and 20g/ day for female) 7.Pregnant or lactating subjects 8.Subjects that the investigator considers need to excluded due to other causes.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Akkermansia muciniphila group(AKK) Berberine Placebo They will be treated with one tablet of AKK and one tablet of Berberine placebo, twice a day, for 12 weeks. Berberine group Berberine They will be treated with one tablet of Berberine and one tablet of AKK placebo, twice a day, for 12 weeks. Berberine group AKK Placebo They will be treated with one tablet of Berberine and one tablet of AKK placebo, twice a day, for 12 weeks. Placebo group AKK Placebo They will be treated with one tablet of AKK placebo and one tablet of Berberine placebo, twice a day, for 12 weeks. Akkermansia muciniphila group(AKK) Akkermansia muciniphila They will be treated with one tablet of AKK and one tablet of Berberine placebo, twice a day, for 12 weeks. Placebo group Berberine Placebo They will be treated with one tablet of AKK placebo and one tablet of Berberine placebo, twice a day, for 12 weeks.
- Primary Outcome Measures
Name Time Method HbA1c after 12weeks Baseline , Day84 Change from baseline in HbA1c
- Secondary Outcome Measures
Name Time Method TEAE and SAE Up to 12 weeks Clinical significant Vital signs, physical and laboratory results
Fasting and OGTT 2h insulin and C-peptide levels after 12weeks Baseline , Day84 Change from baseline in Fasting and OGTT 2h insulin and C-peptide levels
BMI, waist circumference, waist-to-hip ratio after 12weeks Baseline , Day84 Change from baseline in BMI, waist circumference, waist-to-hip ratio
Total body fat and visceral adipose tissue after 12weeks Baseline , Day84 Change from baseline in Total body fat and visceral adipose tissue
Blood lipid profile after 12weeks Baseline , Day84 Change from baseline in Blood lipid profile(include Triglycerides, total cholesterol, LDL-c, HDL-c)
Fasting and OGTT 2h blood glucose levels after 12weeks Baseline , Day84 Change from baseline in Fasting and OGTT 2h blood glucose levels
Weight after 12weeks Baseline , Day84 Change from baseline in weight
HOMA-IR after 12weeks Baseline , Day84 Change from baseline in HOMA-IR
Trial Locations
- Locations (1)
The Seventh Affiliated Hospital of Southern Medical University
🇨🇳Foshan, Guangdong, China