Study on the Molecular Mechanism of Berberine to Improve Type 2 Diabetes Mellitus Complicated With Depression
Recruiting · NCT06979440 · Observational (researchers observe without assigning treatment) · Lead sponsor: Affiliated Hospital of Nantong University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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;
- 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;
- Pregnant or breastfeeding women;
- Alcoholics or drug addicts;
- Those with poor mental condition and unable to cooperate;
- Those who are considered unsuitable for inclusion in the study.
Where it is running
1 location listed.
- Affiliated Hospital of Nantong University - Nantong, Jiangsu, China