Study on the Molecular Mechanism of Berberine 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.

NCT Number	NCT06979440
Lead Sponsor	Affiliated Hospital of Nantong University
Conditions	Diabetes-Related Complications
Enrollment	40 participants
Start Date	2024-11-09
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-05-28