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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
110
one tablet of AKK
one tablet of Berberine
one tablet of placebo
The Seventh Affiliated Hospital of Southern Medical University
Foshan, Guangdong, China
HbA1c after 12weeks
Change from baseline in HbA1c
Time frame: Baseline , Day84
Weight after 12weeks
Change from baseline in weight
Time frame: Baseline , Day84
Fasting and OGTT 2h blood glucose levels after 12weeks
Change from baseline in Fasting and OGTT 2h blood glucose levels
Time frame: Baseline , Day84
HOMA-IR after 12weeks
Change from baseline in HOMA-IR
Time frame: 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
Time frame: Baseline , Day84
BMI, waist circumference, waist-to-hip ratio after 12weeks
Change from baseline in BMI, waist circumference, waist-to-hip ratio
Time frame: Baseline , Day84
Total body fat and visceral adipose tissue after 12weeks
Change from baseline in Total body fat and visceral adipose tissue
Time frame: Baseline , Day84
Blood lipid profile after 12weeks
Change from baseline in Blood lipid profile(include Triglycerides, total cholesterol, LDL-c, HDL-c)
Time frame: Baseline , Day84
TEAE and SAE
Clinical significant Vital signs, physical and laboratory results
Time frame: Up to 12 weeks
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