Investigating how berberine affects type 2 diabetes with depression

Study on the Molecular Mechanism of Berberine Regulating the Gut Microbiota-derived Metabolites 5-AVAB to Improve Type 2 Diabetes Mellitus Complicated With Depression.

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
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Affiliated Hospital of Nantong University (Academic / other)
• Locations: 1 site (Nantong, Jiangsu)
• Trial ID: NCT06979440 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-65 with a diagnosis of type 2 diabetes, with or without comorbid depression.

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.

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 performed: While this specific approach is novel, previous studies have explored the relationship between gut microbiota and metabolic conditions, indicating potential for success.

Eligibility 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 this trial is running

Nantong, Jiangsu

• 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

Conditions Diabetes-Related Complications; Type 2 diabetes mellitus; depression; Diabetes Complications