Study on the Molecular Mechanism of Berberine to Improve Type 2 Diabetes Mellitus Complicated Wit… (NCT06979440) | Clinical Trial Compass
RecruitingNot Applicable
Study on the Molecular Mechanism of Berberine to Improve Type 2 Diabetes Mellitus Complicated With Depression
China40 participantsStarted 2024-11-09
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;