Diabetes-Related ComplicationsSBDDNCT06979440
Study on the Molecular Mechanism of Berberine to Improve Type 2 Diabetes Mellitus Complicated With Depression
An observational study of Diabetes-Related Complications, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
The incidence of type 2 diabetes with comorbid depression (T2DD) is notably high, characterized by prolonged disease duration and susceptibility to recurrence. The preliminary experiments identified 5-AVAB, a gut microbiota-derived metabolite, as a potential novel biomarker for T2DD progression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes-Related Complications
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 9 Nov 2024to 31 Dec 2027
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The Con group was diagnosed with type 2 diabetes and had no history of mental disorders such as depression; The T2DD patient group was diagnosed with type 2 diabetes and depression, where the depression met the DSM-5 diagnostic criteria for recurrent depression without psychotic symptoms or single-episode MDD, and the total score of the HAMD-17 scale was ≥22 points;
Who may be able to join
- Aged 18-65 years (including the critical value), regardless of gender;
- The Con group was diagnosed with type 2 diabetes and had no history of mental disorders such as depression;
- The T2DD patient group was diagnosed with type 2 diabetes and depression, where depression met the DSM-5 diagnostic criteria for recurrent depression without psychotic symptoms or single-episode MDD, and the total score of the HAMD-17 scale was ≥22 points;
- The subjects read and fully understood the patient instructions and signed the informed consent form.
Who cannot join
- Those who do not meet the inclusion criteria;
- Those who have not used antibiotics, prebiotics, probiotics, enteral nutrition drugs, etc. within 3 months before diagnosis, and those who do not use antibiotics, prebiotics, probiotics, enteral nutrition drugs, etc. during treatment;
- Those with progressive serious diseases (such as cancer);
- Those with severe aphasia, agnosia, and apraxia;
- Those who have used psychotropic drugs for a long time within 1 month before the study or have received new drug research in the past 3 months;
- Pregnant or breastfeeding women;
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- Alcoholics or drug addicts;
- Those with poor mental condition and unable to cooperate;
- Those who are considered unsuitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
Zhengwei Zhang, PhD, 15701539317 ext. +86, zhangzhengwei95@foxmail.com
About this study
Official title: Study on the Molecular Mechanism of Berberine Regulating the Gut Microbiota-derived Metabolites 5-AVAB to Improve Type 2 Diabetes Mellitus Complicated With Depression.
The incidence of type 2 diabetes with comorbid depression (T2DD) is notably high, characterized by prolonged disease duration and susceptibility to recurrence. The preliminary experiments identified 5-AVAB, a gut microbiota-derived metabolite, as a potential novel biomarker for T2DD progression. Given the absence of existing research in this area, it warrants in-depth investigation.
The investigators plan to collect fecal and serum samples from participants with type 2 diabetes and those with T2DD to quantify 5-AVAB levels, as well as conduct in vitro gut microbiota culturing and sequencing studies.
Read the detailed description
This study will enroll two groups of participants: a control group (with type 2 diabetes) and a T2DD group (with type 2 diabetes with comorbid depression) (n=20 per group). From each participant, 5 mL of whole blood and 5 g of fresh stool will be collected. The whole blood samples will be processed for serum extraction. The 5-AVAB concentrations in all samples will be quantified using LC-MS/MS and compared between groups.
Anaerobic culture medium will be prepared, and the fresh stool samples will be homogenized with the medium at a ratio of 1 g:20 mL. After 20 minutes of pre-incubation at 37°C under anaerobic conditions, berberine will be added at concentrations of 10 μg/mL, 50 μg/mL, and 100 μg/mL, followed by incubation for 2, 6, 12, and 24 hours. The 5-AVAB levels in each group will then be measured using LC-MS/MS. The additional requirements are as follows:
- Exit and termination criteria If the subject stops the study before sampling, it will be regarded as exit/termination of the study.
- The time the participants participated in the study (each time and total time) The time from the start of the group to the completion of sampling is regarded as the time of participation in the study.
- Recruitment process After review and approval by the Ethics Committee of the Affiliated Hospital of Nantong University, this study can start recruiting. It is planned to recruit in the Department of Endocrinology and Department of Neurology of this hospital, and it is expected to recruit 40 participants without any compensation.
- Conditions
- Diabetes-Related Complications
- Being tested
- No intervention
- Keywords
- Type 2 diabetes mellitus, depression, Diabetes Complications
- Medical subject headings
- Diabetes Complications, Diabetes Mellitus, Type 2, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Control (with type 2 diabetes) | The clinical inclusion criteria are as follows:
a. Age 18-65 years old; b. The Con group was diagnosed with type 2 diabetes and had no history of mental disorders such as depression; c. No antibiotics, prebiotics, probiotics, enteral nutrition drugs, etc. were used within 3 months before diagnosis, and no antibiotics, prebiotics, probiotics, enteral nutrition drugs, etc. were used during treatment. Receives: Other: No intervention | |
| T2DD (with type 2 diabetes complicated with depression) | The clinical inclusion criteria are as follows:
a. Age 18-65 years old; b. The T2DD patient group was diagnosed with type 2 diabetes complicated with depression (depression met the DSM-5 diagnostic criteria); c. No antibiotics, prebiotics, probiotics, enteral nutrition drugs, etc. were used within 3 months before diagnosis, and no antibiotics, prebiotics, probiotics, enteral nutrition drugs, etc. were used during treatment. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The levels of 5-AVAB
There were no additional intervention measures in this study. Faeces were collected after excretion for in vitro drug intervention experiments. The blood collection volume (5 mL) met the ISO international standard and was used to detect the 5-AVAB content in each group.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start9 Nov 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes-Related ComplicationsStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zhengwei zhang, PhD, Principal investigator, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979440
- Sponsor's protocol ID
- 2024-K231-01
- Other IDs
- 82404740, 202495102
- Acronym
- SBDD
- Status last verified
- Jan 2025
- First submitted
- 13 May 2025
- Last updated
- 28 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Molecular Mechanism of Berberine Regulating the Gut Microbiota-derived Metabolites 5-AVAB to Improve Type 2 Diabetes Mellitus Complicated With Depression.
- ClinicalTrials.gov ID
- NCT06979440
- Acronym / sponsor ID
- SBDD / 2024-K231-01
- Conditions
- Diabetes-Related Complications
- Keywords
- Type 2 diabetes mellitus, depression, Diabetes Complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 9 Nov 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 May 2025 (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 incidence of type 2 diabetes with comorbid depression (T2DD) is notably high, characterized by prolonged disease duration and susceptibility to recurrence. The preliminary experiments identified 5-AVAB, a gut microbiota-derived metabolite, as a potential novel biomarker for T2DD progression. Given the absence of existing research in this area, it warrants in-depth investigation.
The investigators plan to collect fecal and serum samples from participants with type 2 diabetes and those with T2DD to quantify 5-AVAB levels, as well as conduct in vitro gut microbiota culturing and sequencing studies.
Detailed description
This study will enroll two groups of participants: a control group (with type 2 diabetes) and a T2DD group (with type 2 diabetes with comorbid depression) (n=20 per group). From each participant, 5 mL of whole blood and 5 g of fresh stool will be collected. The whole blood samples will be processed for serum extraction. The 5-AVAB concentrations in all samples will be quantified using LC-MS/MS and compared between groups.
Anaerobic culture medium will be prepared, and the fresh stool samples will be homogenized with the medium at a ratio of 1 g:20 mL. After 20 minutes of pre-incubation at 37°C under anaerobic conditions, berberine will be added at concentrations of 10 μg/mL, 50 μg/mL, and 100 μg/mL, followed by incubation for 2, 6, 12, and 24 hours. The 5-AVAB levels in each group will then be measured using LC-MS/MS. The additional requirements are as follows:
- Exit and termination criteria If the subject stops the study before sampling, it will be regarded as exit/termination of the study.
- The time the participants participated in the study (each time and total time) The time from the start of the group to the completion of sampling is regarded as the time of participation in the study.
- Recruitment process After review and approval by the Ethics Committee of the Affiliated Hospital of Nantong University, this study can start recruiting. It is planned to recruit in the Department of Endocrinology and Department of Neurology of this hospital, and it is expected to recruit 40 participants without any compensation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (with type 2 diabetes) | – | Other: No interventionThe clinical inclusion criteria are as follows: a. Age 18-65 years old; b. The Con group was diagnosed with type 2 diabetes and had no history of mental disorders such as depression; c. No antibiotics, prebiotics, probiotics, enteral nutrition drugs, etc. were used within 3 months before diagnosis, and no antibiotics, prebiotics, probiotics, enteral nutrition drugs, etc. were used during treatment. |
| T2DD (with type 2 diabetes complicated with depression) | – | Other: No interventionThe clinical inclusion criteria are as follows: a. Age 18-65 years old; b. The T2DD patient group was diagnosed with type 2 diabetes complicated with depression (depression met the DSM-5 diagnostic criteria); c. No antibiotics, prebiotics, probiotics, enteral nutrition drugs, etc. were used within 3 months before diagnosis, and no antibiotics, prebiotics, probiotics, enteral nutrition drugs, etc. were used during treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Con group was diagnosed with type 2 diabetes and had no history of mental disorders such as depression; The T2DD patient group was diagnosed with type 2 diabetes and depression, where the depression met the DSM-5 diagnostic criteria for recurrent depression without psychotic symptoms or single-episode MDD, and the total score of the HAMD-17 scale was ≥22 points;
Key inclusion criteria (4 listed)
- Aged 18-65 years (including the critical value), regardless of gender;
- The Con group was diagnosed with type 2 diabetes and had no history of mental disorders such as depression;
- The T2DD patient group was diagnosed with type 2 diabetes and depression, where depression met the DSM-5 diagnostic criteria for recurrent depression without psychotic symptoms or single-episode MDD, and the total score of the HAMD-17 scale was ≥22 points;
- The subjects read and fully understood the patient instructions and signed the informed consent form.
Key exclusion criteria (9 listed)
- Those who do not meet the inclusion criteria;
- Those who have not used antibiotics, prebiotics, probiotics, enteral nutrition drugs, etc. within 3 months before diagnosis, and those who do not use antibiotics, prebiotics, probiotics, enteral nutrition drugs, etc. during treatment;
- Those with progressive serious diseases (such as cancer);
- Those with severe aphasia, agnosia, and apraxia;
- Those who have used psychotropic drugs for a long time within 1 month before the study or have received new drug research in the past 3 months;
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 |
|---|---|---|
| No interventionNo intervention | Other | Control (with type 2 diabetes), T2DD (with type 2 diabetes complicated with depression) |
Primary outcome
The levels of 5-AVAB
Time frame: 3 years
There were no additional intervention measures in this study. Faeces were collected after excretion for in vitro drug intervention experiments. The blood collection volume (5 mL) met the ISO international standard and was used to detect the 5-AVAB content in each group.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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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.
zhengwei zhang, PhD principal investigator
Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes-Related Complications, run by Affiliated Hospital of Nantong University 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 28 May 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhengwei Zhang, PhD (15701539317 ext. +86, zhangzhengwei95@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The levels of 5-AVAB (time frame: 3 years). 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 28 May 2025.