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

This trial does not accept healthy volunteers

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 population

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 the 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;

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    No intervention

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Control (with type 2 diabetes)1 intervention
Group B: T2DD (with type 2 diabetes complicated with depression)1 intervention

Trial outcomes

Primary outcomes

1

The levels of 5-AVAB

There were no additional intervention measures in this study. Faeces were collected after excretion for in vitro drug intervention experiments. The blood collection volume (5 mL) met the ISO international standard and was used to detect the 5-AVAB content in each group.

Time frame
3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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