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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorAffiliated Hospital of Nantong University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • No intervention

Treatment groups

40 Participants
are divided into 2 treatment groups