NCT06979440

Study on the Molecular Mechanism of Berberine to Improve Type 2 Diabetes Mellitus Complicated 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.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Affiliated Hospital of Nantong University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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. 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: 1. Exit and termination criteria If the subject stops the study before sampling, it will be regarded as exit/termination of the study. 2. 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. 3. 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

Interventions

Type	Name	Description
OTHER	No intervention	No intervention

Timeline

• Start date: 2024-11-09
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-05-20
• Last updated: 2025-05-28

Locations

1 site across 1 country: China