The Seventh Affiliated Hospital of Southern Medical University
Foshan, Guangdong, 514500, China
NCT Number: NCT05720299
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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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Foshan, Guangdong, 514500, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
one tablet of AKK
one tablet of Berberine
one tablet of placebo
Time frame: Baseline , Day84
Change from baseline in HbA1c
Time frame: Baseline , Day84
Change from baseline in weight
Time frame: Baseline , Day84
Change from baseline in Fasting and OGTT 2h blood glucose levels
Time frame: Baseline , Day84
Change from baseline in HOMA-IR
Time frame: Baseline , Day84
Change from baseline in Fasting and OGTT 2h insulin and C-peptide levels
Time frame: Baseline , Day84
Change from baseline in BMI, waist circumference, waist-to-hip ratio
Time frame: Baseline , Day84
Change from baseline in Total body fat and visceral adipose tissue
Time frame: Baseline , Day84
Change from baseline in Blood lipid profile(include Triglycerides, total cholesterol, LDL-c, HDL-c)
Time frame: Up to 12 weeks
Clinical significant Vital signs, physical and laboratory results
Yu Chen
Other
A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effects of Akkermansia Muciniphila and Berberine on Prediabetes Among Obese Subjects.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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