PrediabetesNCT05720299
A Clinical Study to Evaluate the Effects of Akkermansia Muciniphila and Berberine on Prediabetes Among Obese Subjects.
A study testing Akkermansia muciniphila and Berberine in people with Prediabetes, run by Yu Chen at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Prediabetes
- What is being tested?
- Akkermansia muciniphila and Berberine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
- Subjects who has undergone bariatric surgery;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Seventh Affiliated Hospital of Southern Medical University
Foshan, Guangdong, 514500
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effects of Akkermansia Muciniphila and Berberine on Prediabetes Among Obese Subjects.
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.
- Conditions
- Prediabetes
- Being tested
- Akkermansia muciniphila, Berberine, Placebo
- Keywords
- Akkermania muciniphila, obesity, metabolism, fecal flora, Prediabetes
- Medical subject headings
- Prediabetic State, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Akkermansia muciniphilaDrug
one tablet of AKK
BerberineDrug
one tablet of Berberine
PlaceboDrug
one tablet of placebo
| Study group | Role | What they receive |
|---|---|---|
| Akkermansia muciniphila group(AKK) | Experimental | They will be treated with one tablet of AKK, twice a day, for 12 weeks. Receives: Drug: Akkermansia muciniphila |
| Berberine group | Experimental | They will be treated with one tablet of Berberine, twice a day, for 12 weeks. Receives: Drug: Berberine |
| Placebo group | Placebo comparator | They will be treated with one tablet of placebo, twice a day, for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c after 12weeks
Change from baseline in HbA1c
Measured: Baseline , Day84
Secondary outcomes (8)
Weight after 12weeks
Change from baseline in weight
Measured: Baseline , Day84
Fasting and OGTT 2h blood glucose levels after 12weeks
Change from baseline in Fasting and OGTT 2h blood glucose levels
Measured: Baseline , Day84
HOMA-IR after 12weeks
Change from baseline in HOMA-IR
Measured: 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
Measured: Baseline , Day84
BMI, waist circumference, waist-to-hip ratio after 12weeks
Change from baseline in BMI, waist circumference, waist-to-hip ratio
Measured: Baseline , Day84
Total body fat and visceral adipose tissue after 12weeks
Change from baseline in Total body fat and visceral adipose tissue
Measured: Baseline , Day84
Blood lipid profile after 12weeks
Change from baseline in Blood lipid profile(include Triglycerides, total cholesterol, LDL-c, HDL-c)
Measured: Baseline , Day84
TEAE and SAE
Clinical significant Vital signs, physical and laboratory results
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start12 Mar 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yu Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu Chen, The Seventh Affiliated Hospital, Southern Medical University
- Investigators
- Yu Chen, Doctor, Principal investigator, The Seventh Affiliated Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720299
- Sponsor's protocol ID
- ZY19-202201
- Status last verified
- Dec 2025
- First submitted
- 7 Nov 2022
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to protect the privacy and security of the subject, the subject data will not be provided to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effects of Akkermansia Muciniphila and Berberine on Prediabetes Among Obese Subjects.
- ClinicalTrials.gov ID
- NCT05720299
- Acronym / sponsor ID
- ZY19-202201
- Conditions
- Prediabetes
- Keywords
- Akkermania muciniphila, obesity, metabolism, fecal flora, Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Yu ChenUniversity, hospital or other
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Akkermansia muciniphila group(AKK) | Experimental | Drug: Akkermansia muciniphilaThey will be treated with one tablet of AKK, twice a day, for 12 weeks. |
| Berberine group | Experimental | Drug: BerberineThey will be treated with one tablet of Berberine, twice a day, for 12 weeks. |
| Placebo group | Placebo comparator | Drug: PlaceboThey will be treated with one tablet of placebo, twice a day, for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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);
- Subjects who has undergone bariatric surgery;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Akkermansia muciniphilaone tablet of AKK | Drug | Akkermansia muciniphila group(AKK) |
| Berberineone tablet of Berberine | Drug | Berberine group |
| Placeboone tablet of placebo | Drug | Placebo group |
Primary outcome
HbA1c after 12weeks
Time frame: Baseline , Day84
Change from baseline in HbA1c
8 secondary outcomes
Weight after 12weeks
Time frame: Baseline , Day84
Fasting and OGTT 2h blood glucose levels after 12weeks
Time frame: Baseline , Day84
HOMA-IR after 12weeks
Time frame: Baseline , Day84
Fasting and OGTT 2h insulin and C-peptide levels after 12weeks
Time frame: Baseline , Day84
BMI, waist circumference, waist-to-hip ratio after 12weeks
Time frame: Baseline , Day84
Total body fat and visceral adipose tissue after 12weeks
Time frame: Baseline , Day84
Blood lipid profile after 12weeks
Time frame: Baseline , Day84
TEAE and SAE
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Chen, Doctor principal investigator
The Seventh Affiliated Hospital of Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Akkermansia muciniphila and Berberine in people with Prediabetes, run by Yu Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c after 12weeks (time frame: Baseline , Day84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.