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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
1. Aged 18-65 years (including the critical value), regardless of gender;
2. The Con group was diagnosed with type 2 diabetes and had no history of mental disorders such as depression;
3. 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;
4. The subjects read and fully understood the patient instructions and signed the informed consent form.
Exclusion Criteria:
1. Those who do not meet the inclusion criteria;
2. 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;
3. Those with progressive serious diseases (such as cancer);
4. Those with severe aphasia, agnosia, and apraxia;
5. Those who have used psychotropic drugs for a long time within 1 month before the study or have received new drug research in the past 3 months;
6. Pregnant or breastfeeding women;
7. Alcoholics or drug addicts;
8. Those with poor mental condition and unable to cooperate;
9. Those who are considered unsuitable for inclusion in the study.
Primary outcome measure(s)
The levels of 5-AVAB — 3 years 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.
Trial sites (1)
Facility
City
Region
Status
Affiliated Hospital of Nantong University
Nantong
Jiangsu
Recruiting
More Affiliated Hospital of Nantong University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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