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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
No intervention
Other interventionNo intervention
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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