NCT05720299Completed
A Clinical Study to Evaluate the Effects of Akkermansia Muciniphila and Berberine on Prediabetes Among Obese Subjects.
A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effects of Akkermansia Muciniphila and Berberine on Prediabetes Among Obese Subjects.
Source: ClinicalTrials.gov · Last updated 22 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 110 (actual)
- First submitted
- 7 Nov 2022
- Start date
- 12 Mar 2025
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Yu Chen
- Diseases
- Obesity
- NCT number
- NCT05720299
What you commit to
- Study type: Interventional
- Participants enrolled: 110
- From 12 Mar 2025 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who has undergone bariatric surgery;
Other illness
- 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);
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Seventh Affiliated Hospital of Southern Medical University Coordinator of this site? Confirm its status | Foshan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.