Investigating how berberine affects type 2 diabetes with depression
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.
Run by Affiliated Hospital of Nantong University · NCT06979440 · Data updated 2026-11-12
This study is testing how berberine might help people with type 2 diabetes who also have depression by looking at changes in certain gut bacteria and a specific biomarker in their samples.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Affiliated Hospital of Nantong University Academic / other |
| Locations | 1 site (Nantong, Jiangsu) |
| Status | Recruiting |
| Started | November 9, 2024 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | May 28, 2025 |
| Trial ID | NCT06979440 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18-65 with a diagnosis of type 2 diabetes, with or without comorbid depression.
✕Probably not a fit
Patients with severe mental disorders, progressive serious diseases, or those who have recently used certain medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the molecular mechanisms by which berberine may improve outcomes in patients with type 2 diabetes mellitus complicated by depression. It will involve two groups of participants: those with type 2 diabetes and those with both type 2 diabetes and depression. Researchers will collect fecal and serum samples to measure levels of a potential biomarker, 5-AVAB, and analyze gut microbiota through culturing and sequencing. The study seeks to quantify the differences in 5-AVAB levels between the two groups and assess the impact of berberine on these levels over time.
Why it matters
Potential benefit: If successful, this study could lead to new insights into managing type 2 diabetes and depression, potentially improving treatment strategies for patients with these comorbid conditions.
How similar studies have gone: While this specific approach is novel, previous studies have explored the relationship between gut microbiota and metabolic conditions, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18-65 years (including the critical value), regardless of gender; 2. The Con group was diagnosed with type 2 diabetes and had no history of mental disorders such as depression; 3. 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; 4. The subjects read and fully understood the patient instructions and signed the informed consent form. Exclusion Criteria: 1. Those who do not meet the inclusion criteria; 2. 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; 3. Those with progressive serious diseases (such as cancer); 4. Those with severe aphasia, agnosia, and apraxia; 5. 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; 6. Pregnant or breastfeeding women; 7. Alcoholics or drug addicts; 8. Those with poor mental condition and unable to cooperate; 9. Those who are considered unsuitable for inclusion in the study.
Where it's running
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Affiliated Hospital of Nantong University
Nantong, Jiangsu, China Recruiting
Study contacts
- Principal investigator: zhengwei zhang, PhD — Affiliated Hospital of Nantong University
- Study coordinator: Zhengwei Zhang, PhD
- Email: zhangzhengwei95@foxmail.com
- Phone: 15701539317
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.