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

Recruiting

• Conditions: Diabetes-Related Complications

• Registration Number: NCT06979440
• Lead Sponsor: Affiliated Hospital of Nantong University

Brief Summary

The incidence of type 2 diabetes with comorbid depression (T2DD) is notably high, characterized by prolonged disease duration and susceptibility to recurrence. Our 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.

We plan to collect fecal and serum samples from patients 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.

Detailed Description

1. Inclusion criteria (1) Age 18-65 years (including the critical value), regardless of gender; (2) The control 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 complicated by depression, where depression met the DSM-5 diagnostic criteria for recurrent depression without psychotic symptoms or single episode of 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.

2. 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.

3. Exit and termination criteria If the subject stops the study before sampling, it will be regarded as exit/termination of the study.

4. The time the participants participated in the study (each time and total time) The time from the start of the group to the completion of sampling is regarded as the time of participation in the study.

5. Recruitment process After review and approval by the Ethics Committee of the Affiliated Hospital of Nantong University, this study can start recruiting. It is planned to recruit in the Department of Endocrinology and Department of Neurology of this hospital, and it is expected to recruit 40-60 people without any compensation.

Study Timeline

• Study Start: 2024-11-09
• Status Verified: 2025-01
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The levels of 5-AVAB	1 day	There were no additional intervention measures in this study. Faeces were collected after excretion for in vitro drug intervention experiments. The blood collection volume (5 mL) met the ISO international standard and was used to detect the 5-AVAB content in each group.

Trial Locations

Locations (1)

Affiliated Hospital of Nantong University; 🇨🇳 Nantong, Jiangsu, China