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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Akkermansia muciniphila group(AKK) | Experimental | They will be treated with one tablet of AKK, twice a day, for 12 weeks. |
|
| Berberine group | Experimental | They will be treated with one tablet of Berberine, twice a day, for 12 weeks. |
|
| Placebo group | Placebo Comparator | They will be treated with one tablet of placebo, twice a day, for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Akkermansia muciniphila | Drug | one tablet of AKK |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c after 12weeks | Change from baseline in HbA1c | Baseline , Day84 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight after 12weeks | Change from baseline in weight | Baseline , Day84 |
| Fasting and OGTT 2h blood glucose levels after 12weeks | Change from baseline in Fasting and OGTT 2h blood glucose levels |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Yu Chen, Doctor | The Seventh Affiliated Hospital of Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Seventh Affiliated Hospital of Southern Medical University | Foshan | Guangdong | 514500 | China |
In order to protect the privacy and security of the subject, the subject data will not be provided to other researchers
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D001599 | Berberine |
| ID | Term |
|---|---|
| D001600 | Berberine Alkaloids |
| D044182 | Benzylisoquinolines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Berberine |
| Drug |
one tablet of Berberine |
|
| Placebo | Drug | one tablet of placebo |
|
| Baseline , Day84 |
| HOMA-IR after 12weeks | Change from baseline in HOMA-IR | Baseline , Day84 |
| 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 |
| BMI, waist circumference, waist-to-hip ratio after 12weeks | Change from baseline in BMI, waist circumference, waist-to-hip ratio | Baseline , Day84 |
| Total body fat and visceral adipose tissue after 12weeks | Change from baseline in Total body fat and visceral adipose tissue | Baseline , Day84 |
| Blood lipid profile after 12weeks | Change from baseline in Blood lipid profile(include Triglycerides, total cholesterol, LDL-c, HDL-c) | Baseline , Day84 |
| TEAE and SAE | Clinical significant Vital signs, physical and laboratory results | Up to 12 weeks |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |