Evaluating Akkermansia muciniphila and Berberine for Prediabetes in Obese Patients
A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effects of Akkermansia Muciniphila and Berberine on Prediabetes Among Obese Subjects.
This study is testing whether a combination of Akkermansia muciniphila and Berberine can help obese people with prediabetes improve their health over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The Seventh Affiliated Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Foshan, Guangdong) |
| Trial ID | NCT05720299 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Akkermansia muciniphila and Berberine on obese individuals with prediabetes. It employs a randomized, double-blind, placebo-controlled design involving 90 participants, who will be divided into three groups receiving either Akkermansia, Berberine, or a placebo for 12 weeks. The study aims to assess changes in body fat, glucose and lipid metabolism, as well as inflammatory markers and fecal flora structure before and after treatment.
Who should consider this trial
Good fit: Ideal candidates are obese individuals aged 18-65 with prediabetes as defined by specific blood glucose levels.
Not a fit: Patients diagnosed with diabetes mellitus or those with medical obesity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new therapeutic options for managing prediabetes in obese patients.
How similar studies have performed: While the specific combination of Akkermansia muciniphila and Berberine is novel, similar studies targeting gut microbiota and metabolic conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18-65 2. Overweight/obesity (24.0≤BMI≤40.0 kg/m\^2) 3. 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% 4. 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. 5. 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. Exclusion Criteria: 1. 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); 2. Subjects who has undergone bariatric surgery; 3. 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.
Where this trial is running
Foshan, Guangdong
- The Seventh Affiliated Hospital of Southern Medical University — Foshan, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Yu Chen, Doctor — The Seventh Affiliated Hospital of Southern Medical University
- Study coordinator: Yu Chen, Doctor
- Email: askasky@126.com
- Phone: +86-13824482875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.