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Study on the Molecular Mechanism of Berberine to Improve Type 2 Diabetes Mellitus Complicated With Depression

Recruitingn/aAges 18 Years - 65 YearsAllAffiliated Hospital of Nantong University
NCT06979440 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • No intervention
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Where

1 site
Affiliated Hospital of Nantong University
Nantong, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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