Status:
RECRUITING
Study on the Molecular Mechanism of Berberine to Improve Type 2 Diabetes Mellitus Complicated With Depression
Lead Sponsor:
Affiliated Hospital of Nantong University
Conditions:
Diabetes-Related Complications
Eligibility:
All Genders
18-65 years
Brief 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...
Detailed Description
This study will enroll two groups of participants: a control group (with type 2 diabetes) and a T2DD group (with type 2 diabetes with comorbid depression) (n=20 per group). From each participant, 5 mL...
Eligibility Criteria
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 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.
Key Trial Info
Start Date :
November 9 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06979440
Start Date
November 9 2024
End Date
December 31 2027
Last Update
May 28 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226001