Studies a gut-derived substance in type 2 diabetes with depression
Measures a gut microbiota metabolite, 5-AVAB, in adults with diabetes and depression.
Plain-language title generated from the registry record
Registry title: Study on the Molecular Mechanism of Berberine to Improve Type 2 Diabetes Mellitus Complicated With Depression
Key facts
- Where
- Nantong, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06979440, who can take part
Where in China
- Affiliated Hospital of Nantong UniversityNantong, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Affiliated Hospital of Nantong University
- Trial code
- NCT06979440
- Record updated
- 28 May 2025
- Original description
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.Read full original descriptionShow less
Study on the Molecular Mechanism of Berberine Regulating the Gut Microbiota-derived Metabolites 5-AVAB to Improve Type 2 Diabetes Mellitus Complicated With Depression.
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.
Inclusion: 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: 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 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; Alcoholics or drug addicts; Those with progressive serious diseases (such as cancer); Those with poor mental condition and unable to cooperate; Those who do not meet the inclusion criteria; Those with severe aphasia, agnosia, and apraxia; Pregnant or breastfeeding women; Those who are considered unsuitable for inclusion in the study.