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Clinical Trials in China / NCT06979440
Recruiting Observational

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

NCT06979440 · tracked via the Priya Life Science China tracker
Sponsor
Affiliated Hospital of Nantong University
Phase
Observational
Started
2024-11-09
Last updated
2025-05-28

Condition(s) studied

Diabetes-Related Complications

Investigational drug(s) / intervention(s)

No intervention

No intervention: No intervention

Study summary

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)

Trial sites (1)

FacilityCityRegionStatus
Affiliated Hospital of Nantong University Nantong Jiangsu Recruiting

More Affiliated Hospital of Nantong University trials in China

Official registry record

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.

View NCT06979440 on ClinicalTrials.gov ↗ ← All trials in China